CJE · Class II · 21 CFR 862.1050

FDA Product Code CJE: Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

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

124
Total
124
Cleared
62d
Avg days
1976
Since
124 devices
25–48 of 124
Cleared May 20, 1998
ALKALINE PHOSPHATASE (ALKP)
K981245
Abbott Laboratories
Chemistry · 44d
Cleared Feb 12, 1998
ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30
K980316
Diagnostic Chemicals , Ltd.
Chemistry · 16d
Cleared Oct 22, 1997
LIQUID ALKALINE PHOSHATASE REAGENT SET
K973588
Pointe Scientific, Inc.,
Chemistry · 30d
Cleared May 16, 1997
ALP REAGENT SET
K971463
Carolina Liquid Chemistries Corp.
Chemistry · 25d
Cleared Feb 04, 1997
ALKALINE PHOSPHATASE
K964914
Derma Media Lab., Inc.
Chemistry · 57d
Cleared Feb 28, 1996
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
K954840
Sigma Diagnostics, Inc.
Chemistry · 131d
Cleared Nov 27, 1995
ALKALINE PHOSPHATASE REAGENT SYSTEM
K952746
Medical Diagnostic Technologies, Inc.
Chemistry · 164d
Cleared Aug 11, 1995
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
K951584
Sigma Diagnostics, Inc.
Chemistry · 127d
Cleared Dec 29, 1994
ALKALINE PHOSPHATASE (ALKP) QVET
K942997
Prisma Systems
Chemistry · 189d
Cleared May 17, 1994
STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
K941313
Stanbio Laboratory
Chemistry · 60d
Cleared Dec 09, 1993
EMDS ALKANINE PHOSPHATASE (ALP) TEST
K935182
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Sep 08, 1993
AMP ALKALINE PHOSPHATASE REAGENT KIT
K931986
Synermed, Inc.
Chemistry · 139d
Cleared Dec 03, 1992
ALKALINE PHOSPHATASE KIT
K923507
Randox Laboratories, Ltd.
Chemistry · 141d
Cleared Nov 18, 1992
OLYMPUS ALKALINE PHOSPHATASE REAGENT
K925156
Olympus Corp.
Chemistry · 36d
Cleared Nov 09, 1992
EMDS ALKALINE PHOSPHATASE (ALP) TEST
K924574
Em Diagnostic Systems, Inc.
Chemistry · 60d
Cleared Sep 28, 1992
OLYMPUS ALKALINE PHOSPHATASE REAGENT
K923527
Olympus Corp.
Chemistry · 74d
Cleared Nov 22, 1991
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
K913921
Em Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Apr 12, 1991
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483
K910639
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Feb 13, 1991
KINETIC ALKALINE PHOSPHATASE DETERMINATION
K905650
Biochemical Trade, Inc.
Chemistry · 57d
Cleared Dec 28, 1990
ALKALINE PHOSPHATASE
K905684
Amresco, Inc.
Chemistry · 9d
Cleared Sep 27, 1990
SYNERMED ALKALINE PHOSPHATASE REAGENT KIT
K904030
Synermed, Inc.
Chemistry · 27d
Cleared Jul 17, 1990
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
K902560
Roche Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Mar 01, 1990
AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781
K900250
American Research Products Co.
Chemistry · 43d
Cleared Feb 08, 1990
COULTER ALP (ALK PHOS) REAGENT
K900216
Coulter Corp.
Chemistry · 22d