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
73–96 of 124
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 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 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
Cleared Oct 29, 1976
REAGENT, MAGNESIUM CHLORIDE
K760398
J.T. Baker Chemical Co.
Chemistry · 84d
Cleared Aug 26, 1976
ULTRAZYME ALKALINE PHOSPHATASE
K760024
Harleco
Chemistry · 73d
Cleared Aug 26, 1976
REAGENT, P-NITROPHENYL PHOSPHATE
K760399
J.T. Baker Chemical Co.
Chemistry · 20d