JFM · Class II · 21 CFR 862.1110

FDA Product Code JFM: Enzymatic Method, Bilirubin

Leading manufacturers include Siemens Healthcare Diagnostics, Inc., Beckman Instruments, Inc. 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 16, 2005
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
K053090
Beckman Coulter, Inc.
Chemistry · 44d
Cleared Sep 14, 1984
DRI-STAT ENZYMATIC BILIRUBIN TEST KIT
K843174
Beckman Instruments, Inc.
Chemistry · 32d

About Product Code JFM - Regulatory Context