510(k) K131351
- Device
- ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT
- Applicant
- ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC
- 510(k) number
- K131351
- Product code
- CJE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-08-15
- Date received
- 2013-05-10
- Regulation
- 862.1050
- Classification name
- Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HYMAN KATZ
- Address
- 4 Henderson Dr. West Caldwell NJ US 07006 07006
FDA Registration Numbers#
- 8040374
- 8020316
- 2030861
- 2517506
- 3016438761
- 3005333358
- 3006198300
- 3013660430
- 3004493545
- 3011989923
- 9680746
- 3000308930
- 2085064
- 1616487
- 3002809144
- 3010825766
- 3002642396
- 1220972
- 3000148879
- 3005094123
- 3003593973
- 9610126
- 3003795116
- 1319809
- 3004438098
- 1181121
- 3012963943
- 1832216
- 1827821
- 2250051
- 8023024
- 2247288
- 2050012
- 9610529
- 2050010
- 3007662974
- 1319681
Source Documents#
Other 510(k) Records For Product Code CJE #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary