CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Class II
FDA product code CJE covers "Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes", a Class II medical device regulated under 21 CFR 862.1050. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CJE
- Device Class
- Class II
- Regulation Number
- 862.1050
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251074 | truvian health | Tru Liver Health Test Panel | December 19, 2025 |
| K240468 | abbott laboratories diagnostics division | Alkaline Phosphatase | October 16, 2024 |
| K223317 | abbott ireland diagnostics division | Alkaline Phosphatase2 | July 21, 2023 |
| K191245 | horiba abx | Yumizen C1200 ALP, Yumizen C1200 Albumin | August 30, 2019 |
| K171971 | lite-on technology corp. h.s.p.b | Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 | January 25, 2018 |
| K171080 | roche diagnostics operations (rdo) | ALP IFCC Gen.2 | May 10, 2017 |
| K162275 | randox laboratories limited | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | April 21, 2017 |
| K131351 | alfa wassermann diagnostic technologies | ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT | August 15, 2013 |
| K130141 | hitachi chemical diagnostics | S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) | March 22, 2013 |
| K113436 | alfa wassermann | ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT | July 12, 2012 |
| K113269 | elitechgroup | ELITTECH CLINICAL SYSTEMS ALP IFCC SL | December 29, 2011 |
| K101090 | medica | EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS | May 20, 2011 |
| K073191 | thermofisher scientific | ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL | February 28, 2008 |
| K060205 | horiba abx | GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | July 21, 2006 |
| K033185 | roche diagnostics | COBAS INTEGRA ALP IFCC GEN.2 | October 14, 2003 |
| K023807 | abbott laboratories | MODIFICATION TO ALKP | December 26, 2002 |
| K013983 | wiener laboratories saic | WIENER LAB. ALP 405 | January 28, 2002 |
| K012518 | thermo dma | TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 | October 9, 2001 |
| K011599 | jas diagnostics | ALKALINE PHOSPHATASE LIQUID REAGENT | July 20, 2001 |
| K003093 | diagnostic chemicals | ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 | November 27, 2000 |