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 Jun 30, 2005
CREATININE LIQUICOLOR
K050283
Stanbio Laboratory
Chemistry · 143d
Cleared Dec 19, 2002
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098
Roche Diagnostics Corp.
Chemistry · 7d
Cleared Jul 05, 2002
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428
Bayer Corp.
Chemistry · 63d
Cleared Oct 10, 2001
WIENER LAB. CREATININA CINETICA AA
K012065
Wiener Laboratories Saic
Chemistry · 100d
Cleared Jun 20, 2001
BIOSCANNER CREATININE TEST STRIPS
K010456
Polymer Technology Systems, Inc.
Chemistry · 124d
Cleared Nov 16, 2000
CREATININE PLUS
K003261
Roche Diagnostics Corp.
Chemistry · 29d
Cleared May 05, 2000
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K001310
Ortho-Clinical Diagnostics, Inc.
Chemistry · 10d
Cleared Aug 10, 1999
DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE
K984530
Metrika, Inc.
Chemistry · 232d
Cleared Mar 30, 1998
CARESIDE CREATININE
K980043
Exigent Diagnostics, Inc.
Chemistry · 83d
Cleared Oct 31, 1991
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
K912807
Em Diagnostic Systems, Inc.
Chemistry · 128d
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 Sep 09, 1986
CREATININE-E
K863078
J. D. Assoc.
Chemistry · 28d
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