Panels › Clinical Chemistry › Product code JFM · Class 2
Enzymatic Method, Bilirubin
Regulation 862.1110
0510(k)s in 12 months (11 all time)
0recalls in 12 months (9 all time)
6recalls that name a 510(k)
Top companies in JFM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 9, 2017 | K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) Siemens Healthcare Diagnostics, Inc. | JFM |
| Feb 16, 2016 | K152343 | Direct Bilirubin Randox Laboratories Limited, GB | JFM |
| Jan 28, 2016 | K152344 | Total Bilirubin Randox Laboratories Limited, GB | JFM |
| Dec 7, 2007 | K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 Bayer Healthcare, LLC | JFM |
| Dec 30, 2005 | K053132 | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 Wako Chemicals USA, Inc. | JFM |
| Dec 30, 2005 | K053131 | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 Wako Chemicals USA, Inc. | JFM |
| Dec 16, 2005 | K053090 | DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR Beckman Coulter, Inc. | JFM |
| Jun 30, 2005 | K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR Stanbio Laboratory | JFM |
| Apr 21, 1997 | K970985 | WAKO TOTAL BILIRUBIN V Wako Chemicals USA, Inc. | JFM |
| Nov 20, 1990 | K904660 | ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 Diagnostic Chemicals, Ltd. (Usa), CA | JFM |
| Sep 14, 1984 | K843174 | DRI-STAT ENZYMATIC BILIRUBIN TEST KIT Beckman Instruments, Inc. | JFM |
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