FDA Product Code
FDA Product Code LOJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6010
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220176 | Elecsys AFP | Roche Diagnostics | 2022-09-15 | Traditional | PDF ↗ |
| K213626 | VITROS AFP | Ortho Clinical Diagnostics | 2022-06-15 | Traditional | PDF ↗ |
| K090236 | DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 | Siemens Healthcare Diagnostics | 2009-04-27 | Traditional | PDF ↗ |
| K081709 | OLYMPUS AFP - ALPHA-FETOPROTEIN | Olympus Life Science Research Europa GmbH (Europa) | 2009-03-16 | Traditional | PDF ↗ |
| K080017 | VIDAS AFP ASSAY | bioMerieux, Inc. | 2008-09-26 | Traditional | PDF ↗ |
| K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 | Dade Behring, Inc. | 2008-06-04 | Traditional | PDF ↗ |
| K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY | Tosoh Medics, Inc. | 2002-12-17 | Special | PDF ↗ |
| K020807 | AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-10-01 | Traditional | PDF ↗ |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | Bayer Corp. | 2002-03-27 | Special | PDF ↗ |
| K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 | Diagnostic Systems Laboratories, Inc. | 1999-06-21 | Traditional | PDF ↗ |
| K983031 | VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY | Ortho-Clinical Diagnostics, Inc. | 1998-12-18 | Traditional | PDF ↗ |
| K983263 | IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 | Diagnostic Products Corp. | 1998-12-07 | Traditional | PDF ↗ |
| K981282 | ELECSYS AFP | Roche Diagnostics GmbH | 1998-05-01 | Traditional | PDF ↗ |
| K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 | Beckman Instruments, Inc. | 1998-05-01 | Traditional | PDF ↗ |
| K973351 | ELECSYS AFP | Boehringer Mannheim Corp. | 1997-11-21 | Traditional | PDF ↗ |
| K972462 | AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | 1997-09-22 | Traditional | PDF ↗ |
| K851891 | TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS | Richard Scott Elliott | 1985-07-19 | Traditional | PDF ↗ |
Product code LOJ · Class II · Immunology. Data: openFDA.