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 May 29, 1986
ALKALINE PHOSPHATASE PROCEDURE
K861667
Data Medical Associates, Inc.
Chemistry · 29d
Cleared Apr 28, 1986
AP REAGENT CARTRIDGE
K861284
Hi Chem, Inc.
Chemistry · 21d
Cleared Apr 24, 1986
ALP (ALKALINE PHOSPHATASE) REAGENT
K860715
Trace Scientific , Ltd.
Chemistry · 57d
Cleared Feb 06, 1986
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT
K860134
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 21, 1985
IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN
K852441
Clinical Data, Inc.
Chemistry · 72d
Cleared Jul 23, 1985
AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE
K852752
American Research Products Co.
Chemistry · 25d
Cleared Jul 22, 1985
ALKALINE PHOSPHATASE
K852784
Advanced Biomedical Methods, Inc.
Chemistry · 21d
Cleared May 30, 1985
ALP(ALKALINE)(PHOSPHATASE) REAGENT
K851998
Alpkem Corp.
Chemistry · 23d
Cleared Jan 29, 1985
VISION -FORMERLY PDA- ALKALINE PHOSPHATASE
K850110
Abbott Laboratories
Chemistry · 15d
Cleared Sep 14, 1984
ALKALINE PHOSPHATASE REAGENT SET
K843332
Sterling Biochemical, Inc.
Chemistry · 18d
Cleared Sep 13, 1984
SYSTEMATE ALKALINE PHOSPHATASE-67203
K843270
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Jul 18, 1984
ALKALINE PHOSPHATASE ASSAY KIT
K842243
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jun 14, 1984
SIGMA PROCED. 245 ALKALINE PHOSPHATASE
K841918
Sigma Diagnostics, Inc.
Chemistry · 36d
Cleared Jan 30, 1984
KINETIC ALKALINE PHOSPHATASE
K834033
American Monitor Corp.
Chemistry · 68d
Cleared Jan 13, 1984
ALKALINE PHOSPHATASE-RATE
K833744
Seragen Diagnostics, Inc.
Chemistry · 79d
Cleared Sep 12, 1983
RAICHEM ALKALINE PHOSPHATASE REAGENT
K832463
Reagents Applications, Inc.
Chemistry · 48d
Cleared Jun 22, 1983
PARAMAX ALKALINE PHOSPHATASE REAGENT-
K831480
American Dade
Chemistry · 44d
Cleared Jun 08, 1983
DATA-ZYME ALKALINE PHOSPHATASE PROCED
K831360
Data Medical Associates, Inc.
Microbiology · 43d
Cleared Jan 14, 1983
ALKALINE PHOSPHATASE
K823786
Analytical & Research Chemicals, Inc.
Chemistry · 29d
Cleared Nov 22, 1982
DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI
K823213
Boehringer Mannheim Corp.
Chemistry · 25d
Cleared Jul 13, 1982
ULTRAZYME PLUS ALP
K821870
Harleco Diagnostics
Chemistry · 18d
Cleared Jun 02, 1982
ULTRAZYME PLUS ALP #64962,65029&65030
K821471
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Nov 02, 1981
GILCHEM ALP REAGENT
K812912
Gilford Diagnostics
Chemistry · 14d
Cleared Sep 29, 1981
ULTRA ZYME PLUS ALP #64962, 65029 & 30
K812596
Harleco
Chemistry · 18d