FDA 510(k) Applications Submitted by Mark Ko
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220884 |
03/28/2022 |
Disposable Endoscope Valve Sets |
SML Med-Tech Solutions Limited |
| K972714 |
07/21/1997 |
SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K122974 |
09/26/2012 |
TRYOUT-VPS HOLDING PASTE |
CROWN DELTA CORP. |
| K970150 |
01/15/1997 |
MYCOPLASMA IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K230863 |
03/29/2023 |
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit |
ZEUS Scientific |
| K991185 |
04/08/1999 |
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K231616 |
06/02/2023 |
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine |
ZEUS Scientific |
| K212782 |
09/01/2021 |
SternaLock Sternal Closure System |
Biomet Microfixation |
| K213072 |
09/23/2021 |
2.1 x 255mm Drill, 22mm Stop |
Biomet Micofixation |
| K213208 |
09/29/2021 |
Twist Drills |
Biomet Microfixation |
| K213712 |
11/24/2021 |
Pectus Support Bar System |
Biomet Microfixation |
| K010790 |
03/15/2001 |
CORTISOL LIA |
KMI DIAGNOSTICS, INC. |
| K973897 |
10/14/1997 |
DHEA-S |
KMI DIAGNOSTICS, INC. |
| K973898 |
10/14/1997 |
PROGESTERONE ELISA |
KMI DIAGNOSTICS, INC. |
| K973901 |
10/14/1997 |
17 B-ESTRADIOL (ELISA) |
KMI DIAGNOSTICS, INC. |
| K973900 |
10/14/1997 |
TESTOTERONE ELISA |
KMI DIAGNOSTICS, INC. |
| K040111 |
01/20/2004 |
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K990204 |
01/21/1999 |
GLIADIN IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K000363 |
02/04/2000 |
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K000362 |
02/04/2000 |
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K980821 |
03/03/1998 |
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K961012 |
03/13/1996 |
VZV IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K981014 |
03/18/1998 |
ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K981021 |
03/19/1998 |
ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K981020 |
03/19/1998 |
ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K000879 |
03/20/2000 |
THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
| K000880 |
03/20/2000 |
THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
| K961204 |
03/27/1996 |
MUMPS IGG TEST |
ZEUS SCIENTIFIC, INC. |
| K981120 |
03/27/1998 |
ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA |
ZEUS SCIENTIFIC, INC. |
| K961277 |
04/03/1996 |
RF IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K021103 |
04/05/2002 |
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K991179 |
04/07/1999 |
ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K991180 |
04/08/1999 |
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K011244 |
04/23/2001 |
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K971503 |
04/24/1997 |
MYCOPLASMA IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K001393 |
05/03/2000 |
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR |
ZEUS SCIENTIFIC, INC. |
| K991610 |
05/10/1999 |
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. |
ZEUS SCIENTIFIC, INC. |
| K971784 |
05/14/1997 |
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K991820 |
05/27/1999 |
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI |
ZEUS SCIENTIFIC, INC. |
| K992166 |
06/25/1999 |
THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR |
ZEUS SCIENTIFIC, INC. |
| K042092 |
08/03/2004 |
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K042118 |
08/06/2004 |
ATHENA MULTI-LYTE EBV IGG TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K973196 |
08/26/1997 |
ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS |
ZEUS SCIENTIFIC, INC. |
| K946373 |
09/07/1994 |
MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K042416 |
09/07/2004 |
ATHENA MULTI-LYTE ANA-II TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K983376 |
09/25/1998 |
THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S |
ZEUS SCIENTIFIC, INC. |
| K983378 |
09/25/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. |
ZEUS SCIENTIFIC, INC. |
| K993250 |
09/28/1999 |
THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. |
ZEUS SCIENTIFIC, INC. |
| K983418 |
09/29/1998 |
THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL |
ZEUS SCIENTIFIC, INC. |
| K983420 |
09/29/1998 |
THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO |
ZEUS SCIENTIFIC, INC. |
| K983422 |
09/29/1998 |
THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET |
ZEUS SCIENTIFIC, INC. |
| K983423 |
09/29/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
| K983425 |
09/29/1998 |
THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET |
ZEUS SCIENTIFIC, INC. |
| K983426 |
09/29/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC |
ZEUS SCIENTIFIC, INC. |
| K983464 |
10/01/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
| K983465 |
10/01/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
| K983656 |
10/19/1998 |
HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K983805 |
10/28/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO |
ZEUS SCIENTIFIC, INC. |
| K983804 |
10/28/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR |
ZEUS SCIENTIFIC, INC. |
| K983803 |
10/28/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
| K983801 |
10/28/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO |
ZEUS SCIENTIFIC, INC. |
| K964448 |
11/06/1996 |
PROTEINASE-3 IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K964446 |
11/06/1996 |
MYELOPEROXIDASE ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K964449 |
11/06/1996 |
ANCA SCREEN ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K984034 |
11/12/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR |
ZEUS SCIENTIFIC, INC. |
| K984126 |
11/18/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR |
ZEUS SCIENTIFIC, INC. |
| K984123 |
11/18/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E |
ZEUS SCIENTIFIC, INC. |
| K984120 |
11/18/1998 |
THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH |
ZEUS SCIENTIFIC, INC. |
| K984139 |
11/18/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE |
ZEUS SCIENTIFIC, INC. |
| K984138 |
11/18/1998 |
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K984135 |
11/18/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR |
ZEUS SCIENTIFIC, INC. |
| K984133 |
11/18/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH |
ZEUS SCIENTIFIC, INC. |
| K984153 |
11/19/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. |
ZEUS SCIENTIFIC, INC. |
| K984170 |
11/20/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K984175 |
11/20/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K984173 |
11/20/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K984180 |
11/23/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K984181 |
11/23/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K984315 |
12/03/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE |
ZEUS SCIENTIFIC, INC. |
| K984317 |
12/03/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F |
ZEUS SCIENTIFIC, INC. |
| K984347 |
12/04/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F |
ZEUS SCIENTIFIC, INC. |
| K033802 |
12/08/2003 |
ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K984516 |
12/18/1998 |
THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET |
ZEUS SCIENTIFIC, INC. |
| K033977 |
12/23/2003 |
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K190907 |
04/08/2019 |
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System |
ZEUS Scientific, Inc. |
| K191240 |
05/08/2019 |
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System |
ZEUS Scientific Inc. |
| K191398 |
05/24/2019 |
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System |
ZEUS Scientific Inc. |
| K201956 |
07/14/2020 |
Zeus IFA ANA HEp-2 Test System, Zeus dIFine |
Zeus Scientific, Inc. |
| K990207 |
01/21/1999 |
GLIADIN IGA ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
| K051484 |
06/06/2005 |
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. |
ZEUS SCIENTIFIC, INC. |
| K990440 |
02/11/1999 |
GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE |
GENTELL |
| K041028 |
04/21/2004 |
CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL |
CROWN DELTA CORP. |
| K221712 |
06/13/2022 |
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) |
Fotona d.o.o. |
| K182088 |
08/02/2018 |
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro |
Fotona d.o.o. |
| K172819 |
09/18/2017 |
LightWalker Laser System Family |
Fotona d.o.o. |
| K202991 |
09/30/2020 |
Fotona XPulse Pro Laser Platform |
Fotona d.o.o. |
| K213267 |
09/30/2021 |
Dynamis Pro Family |
Fotona d.o.o. |
| K193661 |
12/30/2019 |
LightWalker Laser System Family |
Fotona d.o.o. |
| K193656 |
12/30/2019 |
SkyPulse |
Fotona d.o.o. |
| K211315 |
04/30/2021 |
Comby EEG Caps |
Pamel d.o.o |
| K102460 |
08/27/2010 |
AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH |
SUMMIT MEDICAL PRODUCTS, INC |
| K110814 |
03/24/2011 |
AMBIT TUNNELER |
SUMMIT MEDICAL PRODUCTS, INC |
| K113043 |
10/13/2011 |
DIRECT ANTIBIOTIC INFUSION KIT |
SUMMIT MEDICAL PRODUCTS, INC |
| DEN170081 |
09/29/2017 |
MALDI Biotyper CA System |
Bruker Daltonik GmbH |
| K163536 |
12/16/2016 |
MALDI Biotyper CA (MBT-CA) System, MBT smart CA System |
BRUKER DALTONIK GMBH |
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