Product code CJE
- Device name
- Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1050
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251074 | Tru Liver Health Test Panel | Truvian Health | 2025-12-19 |
| K240468 | Alkaline Phosphatase | Abbott Laboratories Diagnostics Division | 2024-10-16 |
| K223317 | Alkaline Phosphatase2 | Abbott Ireland Diagnostics Division | 2023-07-21 |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | HORIBA ABX SAS | 2019-08-30 |
| K171971 | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer | Lite-On Technology Corp. H.S.P.B. | 2018-01-25 |
| K171080 | ALP IFCC Gen.2 | Roche Diagnostics Operations (Rdo) | 2017-05-10 |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | Randox Laboratories Limited | 2017-04-21 |
| K131351 | ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT | Alfa Wassermann Diagnostic Technologies, LLC | 2013-08-15 |
| K130141 | S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) | Hitachi Chemical Diagnostics, Inc. | 2013-03-22 |
| K113436 | ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT | Alfa Wassermann | 2012-07-12 |
| K113269 | ELITTECH CLINICAL SYSTEMS ALP IFCC SL | Elitechgroup | 2011-12-29 |
| K101090 | EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS | Medica Corp. | 2011-05-20 |
| K073191 | ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL | Thermofisher Scientific OY | 2008-02-28 |
| K060205 | GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | Horiba Abx | 2006-07-21 |
| K033185 | COBAS INTEGRA ALP IFCC GEN.2 | Roche Diagnostics Corp. | 2003-10-14 |
| K023807 | MODIFICATION TO ALKP | Abbott Laboratories | 2002-12-26 |
| K013983 | WIENER LAB. ALP 405 | Wiener Laboratories Saic | 2002-01-28 |
| K012518 | TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 | Thermo Dma, Inc. | 2001-10-09 |
| K011599 | ALKALINE PHOSPHATASE LIQUID REAGENT | Jas Diagnostics, Inc. | 2001-07-20 |
| K003093 | ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 | Diagnostic Chemicals , Ltd. | 2000-11-27 |
| K002285 | ATAC PAK ALP REAGENT KIT | Elan Diagnostics | 2000-09-26 |
| K000067 | ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H | Teco Diagnostics | 2000-01-20 |
| K991762 | ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02 | A.P. Total Care, Inc. | 1999-09-02 |
| K991387 | ELAN ALKALINE PHOSPHATE REAGENT KIT | Elan Holdings, Inc. | 1999-05-19 |
| K990024 | CARESIDE ALKALINE PHOSPHATASE | Careside, Inc. | 1999-01-13 |
| K981897 | ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE | Roche Diagnostic Systems, Inc. | 1998-08-26 |
| K981806 | ALKP | Abbott Laboratories | 1998-06-22 |
| K981245 | ALKALINE PHOSPHATASE (ALKP) | Abbott Laboratories | 1998-05-20 |
| K980316 | ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30 | Diagnostic Chemicals , Ltd. | 1998-02-12 |
| K973588 | LIQUID ALKALINE PHOSHATASE REAGENT SET | Pointe Scientific, Inc., | 1997-10-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850053916014 | IDG/Sanzay | IDG/SANZAY Corporation | 2024-01-03 |
| 10673486002362 | Alkaline Phosphatase Liquid Reagent (Kinetic Procedure) | TECO DIAGNOSTICS | 2023-07-14 |
| 10673486001068 | Alkaline Phosphatase (Kinetic Procedure) | TECO DIAGNOSTICS | 2023-07-14 |
| 10673486001051 | Alkaline Phosphatase (Kinetic Procedure) | TECO DIAGNOSTICS | 2023-07-14 |
| 10673486001044 | Alkaline Phosphatase (ALP) Kinetic Method TC Matrix-240/480 | TECO DIAGNOSTICS | 2023-07-14 |
| 00811727016010 | Pointe Alkaline Phosphatase Reagent | HORIBA INSTRUMENTS INCORPORATED | 2021-01-30 |
| 00811727015709 | Pointe Alkaline Phosphatase on the BS480 | HORIBA INSTRUMENTS INCORPORATED | 2020-05-28 |
| 03610230006832 | Yumizen C1200 ALP | HORIBA ABX SAS | 2020-05-06 |
| 07613336120972 | Alkaline phosphatase acc. to IFCC Gen.2 | Roche Diagnostics GmbH | 2020-03-05 |
| 10758750031801 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2019-11-13 |
| 05055273208207 | ALKALINE PHOSPHATASE (ALP) | RANDOX LABORATORIES LIMITED | 2019-06-03 |
| 00386100002107 | ALP Reagent Kit | MEDICA CORPORATION | 2019-02-14 |
| 15099590000028 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 15099590010034 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 15099590020019 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 15099590060015 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 04015630916436 | Alkaline phosphatase liquid acc to IFCC | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630924837 | Alkaline Phosphatase acc to IFCC Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630921997 | Alkaline phosphatase acc to IFCC Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630919512 | Alkaline Phosphatase acc to IFCC Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630919505 | Alkaline Phosphatase acc to IFCC Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630916443 | Alkaline phosphatase liquid acc to IFCC | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630916429 | Alkaline phosphatase liquid acc to IFCC | Roche Diagnostics GmbH | 2016-09-20 |
| 05055273200300 | ALP | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 05055273200324 | ALP | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 05055273200331 | ALP | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 15099590575168 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590625689 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 10758750008346 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-23 |
| 03610230004890 | ABX PENTRA ALP CP | HORIBA ABX SAS | 2016-05-02 |