FDA 510(k) Applications for Medical Device Product Code "CJE"
(Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K991762 | A.P. TOTAL CARE, INC. | ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 | 09/02/1999 |
| K223317 | Abbott Ireland Diagnostics Division | Alkaline Phosphatase2 | 07/21/2023 |
| K981245 | ABBOTT LABORATORIES | ALKALINE PHOSPHATASE (ALKP) | 05/20/1998 |
| K981806 | ABBOTT LABORATORIES | ALKP | 06/22/1998 |
| K023807 | ABBOTT LABORATORIES | MODIFICATION TO ALKP | 12/26/2002 |
| K113436 | ALFA WASSERMANN | ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT | 07/12/2012 |
| K131351 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC | ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT | 08/15/2013 |
| K990024 | CARESIDE, INC. | CARESIDE ALKALINE PHOSPHATASE | 01/13/1999 |
| K971463 | CAROLINA LIQUID CHEMISTRIES CORP. | ALP REAGENT SET | 05/16/1997 |
| K964914 | DERMA MEDIA LAB., INC. | ALKALINE PHOSPHATASE | 02/04/1997 |
| K980316 | DIAGNOSTIC CHEMICALS LTD. | ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30 | 02/12/1998 |
| K003093 | DIAGNOSTIC CHEMICALS LTD. | ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 | 11/27/2000 |
| K002285 | ELAN DIAGNOSTICS | ATAC PAK ALP REAGENT KIT | 09/26/2000 |
| K991387 | ELAN HOLDINGS, INC. | ELAN ALKALINE PHOSPHATE REAGENT KIT | 05/19/1999 |
| K113269 | ELITECHGROUP | ELITTECH CLINICAL SYSTEMS ALP IFCC SL | 12/29/2011 |
| K130141 | HITACHI CHEMICAL DIAGNOSTICS, INC. | S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) | 03/22/2013 |
| K060205 | HORIBA ABX | GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | 07/21/2006 |
| K191245 | HORIBA ABX SAS | Yumizen C1200 ALP, Yumizen C1200 Albumin | 08/30/2019 |
| K011599 | JAS Diagnostics, Inc. | ALKALINE PHOSPHATASE LIQUID REAGENT | 07/20/2001 |
| K171971 | Lite-On Technology Corp. H.S.P.B. | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer | 01/25/2018 |
| K101090 | MEDICA CORP. | EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS | 05/20/2011 |
| K973588 | POINTE SCIENTIFIC, INC. | LIQUID ALKALINE PHOSHATASE REAGENT SET | 10/22/1997 |
| K162275 | RANDOX LABORATORIES LIMITED | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | 04/21/2017 |
| K981897 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE | 08/26/1998 |
| K033185 | ROCHE DIAGNOSTICS CORP. | COBAS INTEGRA ALP IFCC GEN.2 | 10/14/2003 |
| K171080 | Roche Diagnostics Operations (RDO) | ALP IFCC Gen.2 | 05/10/2017 |
| K954840 | SIGMA DIAGNOSTICS, INC. | ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245 | 02/28/1996 |
| K000067 | TECO DIAGNOSTICS | ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H | 01/20/2000 |
| K012518 | THERMO DMA, INC. | TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 | 10/09/2001 |
| K073191 | THERMO FISHER SCIENTIFIC OY | ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL | 02/28/2008 |
| K013983 | WIENER LABORATORIES S.A.I.C. | WIENER LAB. ALP 405 | 01/28/2002 |
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