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
May 28, 1980K800679REAGENTS FOR DETERM. ALKALINE PHOSPHATAS
Diagnostic Solutions, Inc.
CJE
Feb 11, 1980K800131CENTRIFICHEM ALP/ALKALINE PHOSPHATASE
Union Carbide Corp.
CJE
Dec 7, 1979K792413ELVI ALKALINE PHOSPHATATASE
Volu Sol Medical Industries
CJE
Feb 21, 1979K790065ALKALINE PHOSPHATASE
Macomb Chemical Co.
CJE
Nov 3, 1978K781718ALP REAGENT SET, ALKALINE PHOSPHATASE
Medical Analysis Systems, Inc.
CJE
Oct 24, 1978K781609ALKALINE PHOSPHATASE IN SERUM
Fisher Scientific Co., LLC
CJE
Sep 27, 1978K781472MITROPHENYL, ALKALINE PHOSPHATES
Beckman Instruments, Inc.
CJE
Feb 13, 1978K780095ULTRAZYME PLUS ALP
Harleco
CJE
Feb 7, 1978K780068ALP REAGENT SET
Medical Analysis Systems, Inc.
CJE
Nov 17, 1977K772032GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP
Harleco
CJE
Nov 2, 1977K771829ALKALINE PHOSPHATASE
Gamma Enterprises, Inc.
CJE
Oct 18, 1977K771695ALKALINE PHOSPHATASE TEST
Sclavo, Inc.
CJE
Sep 12, 1977K771470MULTISTAT III ALKALINE PHOSPHATASE
Instrumentation Laboratory CO
CJE
Aug 4, 1977K771085DYNAZYME II ALKALINE PHOSPHATASE
J.T. Baker Chemical Co.
CJE
Jul 14, 1977K770870ULTRAZYME PLUS ALP
Harleco
CJE
Jun 2, 1977K770406TECHNICON SMA & AAII SYSTEMS
Boehringer Laboratories
CJE
Mar 30, 1977K770316ALKALINE PHOSPHATASE ENZYMATIC
Icn Pharmaceuticals, Inc.
CJE
Feb 24, 1977K761315ALKALINE PHOSPHATASE (ALP)/PNPP
Princeton Biomedix
CJE
Nov 24, 1976K760685SIGMA PROCED #SC165
Sigma Chemical Co.
CJE
Nov 1, 1976K760397REAGENT, AMP BUFFER DIAGNOSTIC
J.T. Baker Chemical Co.
CJE
Oct 29, 1976K760474REAGENT, ALKALINE PHOSPHATASE DETERM.
Simmler & Son, Inc.
CJE
Oct 29, 1976K760398REAGENT, MAGNESIUM CHLORIDE
J.T. Baker Chemical Co.
CJE
Aug 26, 1976K760399REAGENT, P-NITROPHENYL PHOSPHATE
J.T. Baker Chemical Co.
CJE
Aug 26, 1976K760024ULTRAZYME ALKALINE PHOSPHATASE
Harleco
CJE

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