FDA 510(k) Applications Submitted by Jack Rogers
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080085 |
01/11/2008 |
MAS TOX CONTROL |
Thermo Fisher Scientific |
| K090282 |
02/05/2009 |
QMS LIDOCAINE |
THERMO FISHER SCIENTIFIC INC. |
| K050419 |
02/18/2005 |
QMS VANCOMYCIN |
SERADYN INC. |
| K220480 |
02/18/2022 |
Revogene |
Meridian Bioscience, Inc |
| K070645 |
03/08/2007 |
SERADYN QMS TOPIRAMATE |
SERADYN INC. |
| K081083 |
04/16/2008 |
CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS |
Thermo Fisher Scientific |
| K051211 |
05/11/2005 |
QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS |
SERADYN INC. |
| K081378 |
05/16/2008 |
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS |
Thermo Fisher Scientific |
| K091617 |
06/03/2009 |
QMS LIDOCAINE CALIBRATORS, MODEL 0374678 |
Thermo Fisher Scientific |
| DEN180040 |
07/30/2018 |
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit |
Meridian Bioscience, Inc. |
| K142302 |
08/18/2014 |
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemis |
Polymer Technology Systems, Inc. |
| K042307 |
08/25/2004 |
ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) |
SERADYN INC. |
| K222779 |
09/14/2022 |
Revogene |
Meridian Bioscience, Inc |
| K182559 |
09/17/2018 |
PREMIER Platinum HpSA PLUS |
Meridian Bioscience, Inc. |
| K062966 |
09/29/2006 |
QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS |
SERADYN INC. |
| K052815 |
10/04/2005 |
QMS AMIKACIN REAGENTS |
SERADYN INC. |
| K052826 |
10/05/2005 |
QMS QUINIDINE. QMS QUINIDINE CALIBRATORS |
SERADYN INC. |
| K983743 |
10/23/1998 |
BISURE LAPAROSCOPIC BIPOLAR FORCEPS |
VALLEYLAB, INC. |
| K083260 |
11/05/2008 |
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN |
Roche Diagnostics |
| K093582 |
11/19/2009 |
ELECSYS CK-MB CALCHECK 5 |
Roche Diagnostics |
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