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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
DateFirm and productCodeLinked 510(k)
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.
Open, Classified		 CJEK190807
Sep 21, 2023Ortho-Clinical Diagnostics, INc.
VITROS XT Chemistry Products ALKP Slides
Open, Classified		 CJEK946090
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/9
Terminated		 CJEK833833
K922072
Sep 26, 2011Abbott Laboratories, Inc
Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the quantitation of alkaline phosphatase in human serum or plasma.
Terminated		 CJEK981806
Mar 27, 2008Pointe Scientific, Inc.
Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Sold by Pointe Scientific, Inc
Terminated		 CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos. 7-A7516-R2-125, 7-A7516-R2-90 and 8-A7516-R2-30, In vitro diagnostic, 30 mL, 90 mL , 125 mL, and 400 mL containers, Sold b
Terminated		 CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos. 7-A7516-R1-120, 7-A7516-R1-500 and 8-A7516-R1-120, In vitro diagnostic, 50 mL, 120 mL , 2 L and 500 mL containers, Sold by
Terminated		 CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Liquid Alk Phos R2 Reagent, Catalog No. 3-A7516-R2, In vitro diagnostic, Sold by Pointe Scientific
Terminated		 CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Liquid Alk Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic, Sold by Pointe Scientific.
Terminated		 CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Sold by Pointe Scientific.
Terminated		 CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Liquid Alkaline Phosphatase (R2) Reagent Set, Catalog No.: H A416-R2, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc
Terminated		 CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Liquid Alkaline Phosphatase Reagent Set, Catalog Nos. A7516-150, A7516-450, A7516-625, HA916-302 and HA916-492, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum
Terminated		 CJEK973588
Aug 10, 2006Pointe Scientific, Inc.
Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml, 125 ml and 400 ml containers, sold by Pointe Scientific; Catalog nos. 7-A7516-R2-125, 7-A7516-R2-30, 7-A7516-R2-400ML, 7-
Terminated		 CJEK973588
Aug 10, 2006Pointe Scientific, Inc.
Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent in 50 ml, 120 ml, 2 L and 500 ml containers, sold by Pointe Scientific; Catalog nos. 7-HA716-R1-50-917, 7-A7516-R1-120, 7-A7516-R1-2L, 7-A
Terminated		 CJEK973588
Aug 10, 2006Pointe Scientific, Inc.
Liquid Alk Phos R2 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R2. In vitro diagnostic.
Terminated		 CJEK973588
Aug 10, 2006Pointe Scientific, Inc.
Liquid Alk Phos R1 Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-R1. In vitro diagnostic.
Terminated		 CJEK973588
Aug 10, 2006Pointe Scientific, Inc.
Liquid Alk Phos Reagent, sold by Pointe Scientific; Catalog no. 3-A7516-L. In vitro diagnostic.
Terminated		 CJEK973588
Aug 10, 2006Pointe Scientific, Inc.
Alkaline Phosphatase Substrate Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 2.1 mL and 7.5mL containers. In vitro diagnostic.
Terminated		 CJEK973588
Aug 10, 2006Pointe Scientific, Inc.
Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 8.4 mL and 30 mL containers. In vitro diagnostic.
Terminated		 CJEK973588
Aug 10, 2006Pointe Scientific, Inc.
Liquid Alkaline Phosphatase (R2) Reagent Set for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.; Catalog no. H A416-R2. In vitro diagnostic.
Terminated		 CJEK973588
Aug 10, 2006Pointe Scientific, Inc.
Liquid Alkaline Phosphatase (R1) Reagent Set for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.; Catalog no. H A416-R1. In vitro diagnostic.
Terminated		 CJEK973588
Aug 10, 2006Pointe Scientific, Inc.
Liquid Alkaline Phosphatase Reagent Set for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc.; Catalog nos. A7516-150, A7516-450, A7516-625, HA7
Terminated		 CJEK973588

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