Product code LOJ— Immunology
ELECSYS AFP
- Classification name
- Kit, Test,Alpha-Fetoprotein For Testicular Cancer
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code LOJ
FDA has cleared devices under product code LOJ between 1985 and 2022, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2022
- 2009
- 2008
- 2002
- 1999
- 1998
- 1997
- 1985
Top applicants under product code LOJ
Recent clearances under product code LOJ
- K220176 — Elecsys AFP
- K213626 — VITROS AFP
- K090236 — DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
- K081709 — OLYMPUS AFP - ALPHA-FETOPROTEIN
- K080017 — VIDAS AFP ASSAY
- K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
- K023894 — ST AIA-PACK AFP ENZYME IMMUNOASSAY
- K020807 — AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K020806 — ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
- K990138 — DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
- K983031 — VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
- K983263 — IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2
- K981282 — ELECSYS AFP
- K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
- K973351 — ELECSYS AFP
- K972462 — AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K851891 — TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS
Data sourced from openFDA. This site is unofficial and independent of the FDA.