JFM · Class II · 21 CFR 862.1110

FDA Product Code JFM: Enzymatic Method, Bilirubin

Leading manufacturers include Wako Chemicals USA, Inc., Stanbio Laboratory and Beckman Coulter, Inc..

11
Total
11
Cleared
104d
Avg days
1984
Since

FDA 510(k) Cleared Enzymatic Method, Bilirubin Devices (Product Code JFM)

11 devices
1–11 of 11
Cleared Mar 09, 2017
ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
K170065
Siemens Healthcare Diagnostics, Inc.
Chemistry · 59d
Cleared Dec 07, 2007
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
K063845
Bayer Healthcare, LLC
Chemistry · 345d
Cleared Dec 30, 2005
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
K053131
Wako Chemicals USA, Inc.
Chemistry · 52d
Cleared Dec 30, 2005
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
K053132
Wako Chemicals USA, Inc.
Chemistry · 52d
Cleared Dec 16, 2005
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
K053090
Beckman Coulter, Inc.
Chemistry · 44d
Cleared Jun 30, 2005
DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
K050266
Stanbio Laboratory
Chemistry · 146d
Cleared Apr 21, 1997
WAKO TOTAL BILIRUBIN V
K970985
Wako Chemicals USA, Inc.
Chemistry · 34d
Cleared Nov 20, 1990
ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
K904660
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 36d
Cleared Sep 14, 1984
DRI-STAT ENZYMATIC BILIRUBIN TEST KIT
K843174
Beckman Instruments, Inc.
Chemistry · 32d

About Product Code JFM - Regulatory Context