Panels › Clinical Chemistry › Product code CIG · Class 2
Diazo Colorimetry, Bilirubin
Regulation 862.1110
1510(k)s in 12 months (235 all time)
0recalls in 12 months (19 all time)
19recalls that name a 510(k)
Top companies in CIG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 22, 1998 | K981943 | DBIL Abbott Laboratories | CIG |
| Jul 7, 1998 | K981883 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 Boehringer Mannheim Corp. | CIG |
| Jun 23, 1998 | K981588 | CARESIDE TOTAL BILIRUBIN Careside, Inc. | CIG |
| Jun 15, 1998 | K981632 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT Roche Diagnostics/Boehringer Mannheim GmbH | CIG |
| Jun 3, 1998 | K981609 | BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 Diagnostic Chemicals , Ltd., CA | CIG |
| May 1, 1998 | K981336 | TBIL Abbott Laboratories | CIG |
| May 1, 1998 | K981276 | N-ASSAY L D-BIL Crestat Diagnostics, Inc. | CIG |
| Apr 27, 1998 | K981289 | N-ASSAY L T-BIL Crestat Diagnostics, Inc. | CIG |
| Apr 24, 1998 | K981222 | DIRECT BILIRUBIN (DBIL) Abbott Laboratories | CIG |
| Feb 12, 1998 | K974874 | BILIRUBIN-SL (TOTAL) ASSAY Diagnostic Chemicals, Ltd. (Usa), CA | CIG |
| Sep 25, 1997 | K973109 | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
| Aug 7, 1997 | K972716 | SYNERMED TOTAL BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
| Jun 24, 1997 | K972073 | TOTAL BILIRUBIN REAGENT Carolina Liquid Chemistries Corp. | CIG |
| May 7, 1997 | K970986 | WAKO DIRECT BILIRUBIN V Wako Chemicals USA, Inc. | CIG |
| Dec 18, 1996 | K963939 | SYNERMED DIRECT BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
| Aug 27, 1996 | K955880 | DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 Diagnostic Chemicals , Ltd., CA | CIG |
| Mar 13, 1996 | K955940 | TOTAL BILIRUBIN REAGENT Derma Media Lab., Inc. | CIG |
| Dec 20, 1995 | K955300 | TOTAL BILIRUBIN PROCEDURE Data Medical Associates, Inc. | CIG |
| Dec 2, 1994 | K942999 | BILIRUBIN(TOTAL) QVET Prisma Systems | CIG |
| Nov 22, 1994 | K942949 | BILIRUBIN (DIRECT) QVET Prisma Systems | CIG |
| Apr 26, 1994 | K934068 | BECKMAN DIRECT BILIRUBIN REAGENT Beckman-Diagnostic Systems Group | CIG |
| Apr 20, 1994 | K940570 | SYNERMED TOTAL BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
| Oct 28, 1993 | K933026 | SYNERMED DIRECT BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
| Sep 21, 1993 | K932159 | SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406 Em Diagnostic Systems, Inc. | CIG |
| Jul 27, 1993 | K931888 | TOTAL BILIRUBIN Em Diagnostic Systems, Inc. | CIG |
| Jun 29, 1993 | K930679 | DIRECT BILIRUBIN Horizon Diagnostics, Inc. | CIG |
| Dec 3, 1992 | K924964 | OLYMPUS TOTAL BILIRUBIN REAGENT Olympus Corp. | CIG |
| Nov 30, 1992 | K924963 | OLYMPUS DIRECT BILIRUBIN REAGENT Olympus Corp. | CIG |
| Oct 2, 1992 | K923609 | OLYMPUS TOTAL BILIRUBIN REAGENT Olympus Corp. | CIG |
| Sep 9, 1992 | K923083 | TOTAL BILIRUBIN CATALOG NO. 65407 Em Diagnostic Systems, Inc. | CIG |
| Sep 9, 1992 | K922856 | SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000 Em Diagnostic Systems, Inc. | CIG |
| Aug 18, 1992 | K923608 | OLYMPUS DIRECT BILIRUBIN REAGENT Olympus Corp. | CIG |
| Jul 23, 1992 | K920653 | IL TEST BILIRUBIN TOTAL/DIRECT Instrumentation Laboratory CO | CIG |
| Jul 21, 1992 | K921844 | KODAK EKTACHEM DT SLIDES (NBIL) Eastman Kodak Company | CIG |
| Dec 4, 1991 | K914873 | DIAZO COLORIMETRY, BILIRUBIN Pointe Scientific, Inc., | CIG |
| Oct 25, 1991 | K913466 | ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20 Em Diagnostic Systems, Inc. | CIG |
| Oct 11, 1991 | K913307 | ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21 Em Diagnostic Systems, Inc. | CIG |
| Jul 22, 1991 | K912733 | AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT Amersham Corp. | CIG |
| Jul 17, 1991 | K911866 | TRACE TOTAL/DIRECT BILIRUBIN REAGENT Trace Scientific , Ltd., AU | CIG |
| May 15, 1991 | K910635 | TOTAL BILIRUBIN REAGENT SET Biochemical Trade, Inc. | CIG |
| Apr 24, 1991 | K910593 | ROCHE REAGENT FOR DIRECT BILIRUBIN Roche Diagnostic Systems, Inc. | CIG |
| Apr 24, 1991 | K910591 | ROCHE REAGENT FOR TOTAL BILIRUBIN Roche Diagnostic Systems, Inc. | CIG |
| Jan 17, 1991 | K904468 | DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 Amresco, Inc. | CIG |
| Dec 26, 1990 | K905622 | COULTER DIRECT BILLRUBIN REAGENT Coulter Electronics, Inc. | CIG |
| Oct 12, 1990 | K904381 | DIAZO COLORIMENTRY DIRECT BILIRUBIN Amresco, Inc. | CIG |
| Sep 21, 1990 | K903728 | SYNERMED DIRECT BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
| Jul 17, 1990 | K902801 | BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT Beckman Instruments, Inc. | CIG |
| Jun 28, 1990 | K902328 | SYNERMED TOTAL BILIRUBIN REAGENT KIT Synermed, Inc., CA | CIG |
| Jun 12, 1990 | K902199 | COULTER DIRECT BILIRUBIN Coulter Corp. | CIG |
| Jun 6, 1990 | K902123 | SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406 Em Diagnostic Systems, Inc. | CIG |
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