CJE · Class II · 21 CFR 862.1050

FDA Product Code CJE: Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Leading manufacturers include Em Diagnostic Systems, Inc., Abbott Laboratories and Harleco.

124
Total
124
Cleared
62d
Avg days
1976
Since
124 devices
97–120 of 124
Cleared Sep 09, 1981
ALKALINE PHOSPHATASE
K812452
Pointe Scientific, Inc.,
Chemistry · 12d
Cleared Jan 26, 1981
ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT
K810082
Bio-Analytics Laboratories, Inc.
Chemistry · 13d
Cleared Nov 12, 1980
BECKMAN LIQUID STAT LIQUID/ALKALINE PHO
K802574
Beckman Instruments, Inc.
Chemistry · 26d
Cleared Jun 20, 1980
COBAS REAGENT FOR ALKALINE PHOSPHATASE
K801242
Roche Analytical Instruments, Inc.
Chemistry · 24d
Cleared May 28, 1980
REAGENTS FOR DETERM. ALKALINE PHOSPHATAS
K800679
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared Feb 11, 1980
CENTRIFICHEM ALP/ALKALINE PHOSPHATASE
K800131
Union Carbide Corp.
Chemistry · 24d
Cleared Dec 07, 1979
ELVI ALKALINE PHOSPHATATASE
K792413
Volu Sol Medical Industries
Chemistry · 11d
Cleared Feb 21, 1979
ALKALINE PHOSPHATASE
K790065
Macomb Chemical Co.
Chemistry · 37d
Cleared Nov 03, 1978
ALP REAGENT SET, ALKALINE PHOSPHATASE
K781718
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Oct 24, 1978
ALKALINE PHOSPHATASE IN SERUM
K781609
Fisher Scientific Co., LLC
Hematology · 35d
Cleared Sep 27, 1978
MITROPHENYL, ALKALINE PHOSPHATES
K781472
Beckman Instruments, Inc.
Chemistry · 30d
Cleared Feb 13, 1978
ULTRAZYME PLUS ALP
K780095
Harleco
Chemistry · 26d
Cleared Feb 07, 1978
ALP REAGENT SET
K780068
Medical Analysis Systems, Inc.
Chemistry · 22d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP
K772032
Harleco
Chemistry · 21d
Cleared Nov 02, 1977
ALKALINE PHOSPHATASE
K771829
Gamma Enterprises, Inc.
Chemistry · 42d
Cleared Oct 18, 1977
ALKALINE PHOSPHATASE TEST
K771695
Sclavo, Inc.
Chemistry · 42d
Cleared Sep 12, 1977
MULTISTAT III ALKALINE PHOSPHATASE
K771470
Instrumentation Laboratory CO
Chemistry · 39d
Cleared Aug 04, 1977
DYNAZYME II ALKALINE PHOSPHATASE
K771085
J.T. Baker Chemical Co.
Chemistry · 49d
Cleared Jul 14, 1977
ULTRAZYME PLUS ALP
K770870
Harleco
Chemistry · 62d
Cleared Jun 02, 1977
TECHNICON SMA & AAII SYSTEMS
K770406
Boehringer Laboratories
Chemistry · 91d
Cleared Mar 30, 1977
ALKALINE PHOSPHATASE ENZYMATIC
K770316
Icn Pharmaceuticals, Inc.
Chemistry · 42d
Cleared Feb 24, 1977
ALKALINE PHOSPHATASE (ALP)/PNPP
K761315
Princeton Biomedix
Chemistry · 63d
Cleared Nov 24, 1976
SIGMA PROCED #SC165
K760685
Sigma Chemical Co.
Chemistry · 65d
Cleared Nov 01, 1976
REAGENT, AMP BUFFER DIAGNOSTIC
K760397
J.T. Baker Chemical Co.
Chemistry · 87d