JFY · Class II · 21 CFR 862.1225

FDA Product Code JFY: Enzymatic Method, Creatinine

Leading manufacturers include Ortho-Clinical Diagnostics, Inc., Boehringer Mannheim Corp. and Siemens Healthcare Diagnostics, Inc..

49
Total
49
Cleared
134d
Avg days
1981
Since
49 devices
25–48 of 49
Cleared Aug 12, 1991
REFLOTRON CREATININE TEST TABS
K913105
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared Sep 07, 1990
REFLOTRON CREATININE TEST TABS
K903573
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared Feb 24, 1988
KODAK EKTACHEM DT SLIDES (CRSC)
K875191
Eastman Kodak Company
Chemistry · 69d
Cleared Feb 12, 1987
RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)
K864992
Reagents Applications, Inc.
Chemistry · 52d
Cleared Jan 17, 1986
CREATININE PAP
K854766
Boehringer Mannheim Corp.
Chemistry · 51d
Cleared May 01, 1984
CREATININE REAGENT SET
K841070
Medical Specialties, Inc.
Chemistry · 50d
Cleared Aug 31, 1981
ENXYMATIC CREATININE TEST
K812095
Boehringer Mannheim Corp.
Chemistry · 38d