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
49–72 of 124
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 Apr 18, 1988
RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.
K880795
Trace America, Inc.
Chemistry · 52d
Cleared Apr 18, 1988
ALKALINE PHOSPHATASE REAGENT, DEA BUFF
K880796
Trace America, Inc.
Chemistry · 52d
Cleared Mar 15, 1988
ALKALINE PHOSPHATASE REAGENT SET
K880307
Tech-Neal Scientific, Inc.
Chemistry · 50d
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 07, 1987
MULTICHEM ALKALINE PHOSPHATASE (S0903)
K873761
Simmler, Inc.
Chemistry · 21d
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 Dec 04, 1986
U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST
K863980
U. S. Diagnostics, Inc.
Chemistry · 51d
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
KINETIC ALKALINE PHOSPHATASE REAGENT KIT
K861638
Bio-Analytics Laboratories, Inc.
Chemistry · 29d
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