FDA 510(k) Applications Submitted by TONYA MALLORY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K030065 |
01/07/2003 |
WAKO NEFA LINEARITY SET |
WAKO CHEMICALS, USA, INC. |
| K010325 |
02/02/2001 |
WAKO AUTOKIT C4 |
WAKO CHEMICALS, USA, INC. |
| K010326 |
02/02/2001 |
WAKO AUTOKIT C3 |
WAKO CHEMICALS, USA, INC. |
| K010332 |
02/02/2001 |
WAKO IMMUNOASSAY CALIBRATOR SET |
WAKO CHEMICALS, USA, INC. |
| K010334 |
02/02/2001 |
WAKO LIPID CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
| K960874 |
03/04/1996 |
COMPLEMENT CONTROL |
WAKO CHEMICALS, USA, INC. |
| K970985 |
03/18/1997 |
WAKO TOTAL BILIRUBIN V |
WAKO CHEMICALS, USA, INC. |
| K970986 |
03/18/1997 |
WAKO DIRECT BILIRUBIN V |
WAKO CHEMICALS, USA, INC. |
| K020972 |
03/26/2002 |
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET |
WAKO CHEMICALS, USA, INC. |
| K001002 |
03/29/2000 |
WAKO LIPASE CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
| K001004 |
03/29/2000 |
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
| K001005 |
03/29/2000 |
WAKO HDL-C/LDL-C CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
| DEN050002 |
04/07/2005 |
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS |
WAKO CHEMICALS, USA, INC. |
| K981446 |
04/22/1998 |
WAKO AUTOKIT LP(A) |
WAKO CHEMICALS, USA, INC. |
| K001919 |
06/23/2000 |
WAKO AUTOKIT LP(A)/DADE DEMENSION |
WAKO CHEMICALS, USA, INC. |
| K001920 |
06/23/2000 |
WAKO AUTOKIT LP(A)/ RA,500/1000, |
WAKO CHEMICALS, USA, INC. |
| K001921 |
06/23/2000 |
WAKO AUTOKIT LP(A)/EXPRESS 550 |
WAKO CHEMICALS, USA, INC. |
| K001929 |
06/26/2000 |
WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA |
WAKO CHEMICALS, USA, INC. |
| K001931 |
06/26/2000 |
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET |
WAKO CHEMICALS, USA, INC. |
| K001933 |
06/26/2000 |
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO |
WAKO CHEMICALS, USA, INC. |
| K001934 |
06/26/2000 |
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX |
WAKO CHEMICALS, USA, INC. |
| K982271 |
06/29/1998 |
WAKO DIRECT LDL-C |
WAKO CHEMICALS, USA, INC. |
| K973055 |
08/15/1997 |
WAKO CH50 LINEARITY SET |
WAKO CHEMICALS, USA, INC. |
| K973072 |
08/18/1997 |
WAKO NEFA LINEARITY SET |
WAKO CHEMICALS, USA, INC. |
| K993162 |
09/22/1999 |
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
| K963847 |
09/25/1996 |
WAKO DIRECT HDL-C |
WAKO CHEMICALS, USA, INC. |
| K993219 |
09/27/1999 |
WAKO BILIRUBIN CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
| K993466 |
10/13/1999 |
WAKO L-TYPE TRIGLYCERIDE TEST |
WAKO CHEMICALS, USA, INC. |
| K993468 |
10/13/1999 |
WAKO L-TYPE GOT TEST |
WAKO CHEMICALS, USA, INC. |
| K993469 |
10/13/1999 |
WAKO L-TYPE UA F TEST |
WAKO CHEMICALS, USA, INC. |
| K955156 |
11/13/1995 |
WAKO AUTOKIT CRP NEW |
WAKO CHEMICALS, USA, INC. |
| K984119 |
11/18/1998 |
WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
| K984122 |
11/18/1998 |
WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
| K993924 |
11/18/1999 |
WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD |
WAKO CHEMICALS, USA, INC. |
| K993925 |
11/18/1999 |
WAKO L-TYPE UN TEST |
WAKO CHEMICALS, USA, INC. |
| K993927 |
11/18/1999 |
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD |
WAKO CHEMICALS, USA, INC. |
| K984184 |
11/23/1998 |
WAKO L-TYPE AMYLASE |
WAKO CHEMICALS, USA, INC. |
| K033860 |
12/12/2003 |
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
| K024280 |
12/23/2002 |
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET |
WAKO CHEMICALS, USA, INC. |
| K024281 |
12/23/2002 |
WAKO L-TYPE GLUCOSE 2 |
WAKO CHEMICALS, USA, INC. |
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