Panels › Immunology › Product code LOJ · Class 2
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Regulation 866.6010
0510(k)s in 12 months (17 all time)
0recalls in 12 months (7 all time)
3recalls that name a 510(k)
Top companies in LOJ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 15, 2022 | K220176 | Elecsys AFP Roche Diagnostics | LOJ |
| Jun 15, 2022 | K213626 | VITROS AFP Ortho Clinical Diagnostics, GB | LOJ |
| Apr 27, 2009 | K090236 | DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 Siemens Healthcare Diagnostics | LOJ |
| Mar 16, 2009 | K081709 | OLYMPUS AFP - ALPHA-FETOPROTEIN Olympus Life Science Research Europa GmbH (Europa), IE | LOJ |
| Sep 26, 2008 | K080017 | VIDAS AFP ASSAY bioMerieux, Inc. | LOJ |
| Jun 4, 2008 | K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 Dade Behring, Inc. | LOJ |
| Dec 17, 2002 | K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY Tosoh Medics, Inc. | LOJ |
| Oct 1, 2002 | K020807 | AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Diagnostics Corp. | LOJ |
| Mar 27, 2002 | K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY Bayer Corp. | LOJ |
| Jun 21, 1999 | K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 Diagnostic Systems Laboratories, Inc. | LOJ |
| Dec 18, 1998 | K983031 | VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY Ortho-Clinical Diagnostics, Inc. | LOJ |
| Dec 7, 1998 | K983263 | IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 Diagnostic Products Corp. | LOJ |
| May 1, 1998 | K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 Beckman Instruments, Inc. | LOJ |
| May 1, 1998 | K981282 | ELECSYS AFP Roche Diagnostics GmbH | LOJ |
| Nov 21, 1997 | K973351 | ELECSYS AFP Boehringer Mannheim Corp. | LOJ |
| Sep 22, 1997 | K972462 | AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM Bayer Corp. | LOJ |
| Jul 19, 1985 | K851891 | TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS Richard Scott Elliott | LOJ |
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