ClearanceBrief
Panels › Clinical Chemistry › Product code CJE · Class 2

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Regulation 862.1050

1510(k)s in 12 months (124 all time)
0recalls in 12 months (22 all time)
22recalls that name a 510(k)
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Top companies in CJE

Company510(k)sRecalls
Pointe Scientific, Inc.,218
Em Diagnostic Systems, Inc.100
Abbott Laboratories51
Harleco50
Diagnostic Chemicals , Ltd.40
J.T. Baker Chemical Co.40
Sigma Diagnostics, Inc.40
Data Medical Associates, Inc.30
American Research Products Co.20
Beckman Instruments, Inc.20
Decided510(k)Device and applicantCode
Feb 8, 1990K900216COULTER ALP (ALK PHOS) REAGENT
Coulter Corp.
CJE
Oct 31, 1989K895250SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402
Em Diagnostic Systems, Inc.
CJE
Mar 24, 1989K890521ABBOTT CLINICAL CHEMISTRY REAGENT ALP
Abbott Laboratories
CJE
Nov 10, 1988K884549ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
Em Diagnostic Systems, Inc.
CJE
Jul 8, 1988K881742BIOTROL ALKALINE PHOSPHATASE
Biotrol, USA, Inc.
CJE
Apr 18, 1988K880796ALKALINE PHOSPHATASE REAGENT, DEA BUFF
Trace America, Inc.
CJE
Apr 18, 1988K880795RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.
Trace America, Inc.
CJE
Mar 15, 1988K880307ALKALINE PHOSPHATASE REAGENT SET
Tech-Neal Scientific, Inc.
CJE
Feb 2, 1988K875210ALKALINE PHOSPHATASE CAT. # 306-22, 306-23
Diagnostic Chemicals, Ltd. (Usa)
CJE
Oct 29, 1987K873635EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
Em Diagnostic Systems, Inc.
CJE
Oct 7, 1987K873761MULTICHEM ALKALINE PHOSPHATASE (S0903)
Simmler, Inc.
CJE
Oct 2, 1987K873333WAKO(TM) AUTOKIT ALP
Wako Chemicals USA, Inc.
CJE
Sep 29, 1987K873681ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95
Em Diagnostic Systems, Inc.
CJE
Jun 22, 1987K871543ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.
Catachem, Inc.
CJE
Jan 13, 1987K864905ALKALINE PHOSPHATASE
Tech-Co, Inc.
CJE
Dec 4, 1986K863980U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST
U. S. Diagnostics, Inc.
CJE
Sep 29, 1986K863268ALKALINE PHOSPHATASE PROCEDURE
Data Medical Associates, Inc.
CJE
Sep 26, 1986K862498ALKALINE PHOSPHATASE TEST
King Diagnostics, Inc.
CJE
Sep 9, 1986K863051ALP S.C.E.
J. D. Assoc.
CJE
Aug 29, 1986K862905ALP (OPT) REAGENT
Sigma Diagnostics, Inc.
CJE
Jul 1, 1986K862256ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET
Sterling Diagnostics, Inc.
CJE
May 29, 1986K861667ALKALINE PHOSPHATASE PROCEDURE
Data Medical Associates, Inc.
CJE
May 29, 1986K861638KINETIC ALKALINE PHOSPHATASE REAGENT KIT
Bio-Analytics Laboratories, Inc.
CJE
Apr 28, 1986K861284AP REAGENT CARTRIDGE
Hi Chem, Inc.
CJE
Apr 24, 1986K860715ALP (ALKALINE PHOSPHATASE) REAGENT
Trace Scientific , Ltd., AU
CJE
Feb 6, 1986K860134EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT
Em Diagnostic Systems, Inc.
CJE
Aug 21, 1985K852441IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN
Clinical Data, Inc.
CJE
Jul 23, 1985K852752AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE
American Research Products Co.
CJE
Jul 22, 1985K852784ALKALINE PHOSPHATASE
Advanced Biomedical Methods, Inc.
CJE
May 30, 1985K851998ALP(ALKALINE)(PHOSPHATASE) REAGENT
Alpkem Corp.
CJE
Jan 29, 1985K850110VISION -FORMERLY PDA- ALKALINE PHOSPHATASE
Abbott Laboratories
CJE
Sep 14, 1984K843332ALKALINE PHOSPHATASE REAGENT SET
Sterling Biochemical, Inc.
CJE
Sep 13, 1984K843270SYSTEMATE ALKALINE PHOSPHATASE-67203
Em Diagnostic Systems, Inc.
CJE
Jul 18, 1984K842243ALKALINE PHOSPHATASE ASSAY KIT
Diagnostic Chemicals, Ltd. (Usa)
CJE
Jun 14, 1984K841918SIGMA PROCED. 245 ALKALINE PHOSPHATASE
Sigma Diagnostics, Inc.
CJE
Jan 30, 1984K834033KINETIC ALKALINE PHOSPHATASE
American Monitor Corp.
CJE
Jan 13, 1984K833744ALKALINE PHOSPHATASE-RATE
Seragen Diagnostics, Inc.
CJE
Sep 12, 1983K832463RAICHEM ALKALINE PHOSPHATASE REAGENT
Reagents Applications, Inc.
CJE
Jun 22, 1983K831480PARAMAX ALKALINE PHOSPHATASE REAGENT-
American Dade
CJE
Jun 8, 1983K831360DATA-ZYME ALKALINE PHOSPHATASE PROCED
Data Medical Associates, Inc.
CJE
Jan 14, 1983K823786ALKALINE PHOSPHATASE
Analytical & Research Chemicals, Inc.
CJE
Nov 22, 1982K823213DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI
Boehringer Mannheim Corp.
CJE
Jul 13, 1982K821870ULTRAZYME PLUS ALP
Harleco Diagnostics
CJE
Jun 2, 1982K821471ULTRAZYME PLUS ALP #64962,65029&65030
Emd Chemicals, Inc.
CJE
Nov 2, 1981K812912GILCHEM ALP REAGENT
Gilford Diagnostics
CJE
Sep 29, 1981K812596ULTRA ZYME PLUS ALP #64962, 65029 & 30
Harleco
CJE
Sep 9, 1981K812452ALKALINE PHOSPHATASE
Pointe Scientific, Inc.,
CJE
Jan 26, 1981K810082ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT
Bio-Analytics Laboratories, Inc.
CJE
Nov 12, 1980K802574BECKMAN LIQUID STAT LIQUID/ALKALINE PHO
Beckman Instruments, Inc.
CJE
Jun 20, 1980K801242COBAS REAGENT FOR ALKALINE PHOSPHATASE
Roche Analytical Instruments, Inc.
CJE

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