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 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 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
Cleared Oct 31, 1989
SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402
K895250
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Mar 24, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT ALP
K890521
Abbott Laboratories
Chemistry · 50d
Cleared Nov 10, 1988
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
K884549
Em Diagnostic Systems, Inc.
Chemistry · 10d
Cleared Jul 08, 1988
BIOTROL ALKALINE PHOSPHATASE
K881742
Biotrol, USA, Inc.
Chemistry · 77d
Cleared Feb 02, 1988
ALKALINE PHOSPHATASE CAT. # 306-22, 306-23
K875210
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Oct 29, 1987
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
K873635
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Oct 02, 1987
WAKO(TM) AUTOKIT ALP
K873333
Wako Chemicals USA, Inc.
Chemistry · 44d
Cleared Sep 29, 1987
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95
K873681
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared Jun 22, 1987
ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.
K871543
Catachem, Inc.
Chemistry · 63d
Cleared Jan 13, 1987
ALKALINE PHOSPHATASE
K864905
Tech-Co, Inc.
Chemistry · 29d
Cleared Sep 29, 1986
ALKALINE PHOSPHATASE PROCEDURE
K863268
Data Medical Associates, Inc.
Chemistry · 35d
Cleared Sep 26, 1986
ALKALINE PHOSPHATASE TEST
K862498
King Diagnostics, Inc.
Chemistry · 87d
Cleared Sep 09, 1986
ALP S.C.E.
K863051
J. D. Assoc.
Chemistry · 28d
Cleared Aug 29, 1986
ALP (OPT) REAGENT
K862905
Sigma Diagnostics, Inc.
Chemistry · 29d
Cleared Jul 01, 1986
ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET
K862256
Sterling Diagnostics, Inc.
Chemistry · 18d
Cleared May 29, 1986
ALKALINE PHOSPHATASE PROCEDURE
K861667
Data Medical Associates, Inc.
Chemistry · 29d