Atlas FDA

LOJ

17 FDA 510(k) clearances · Product code

84 daysmedian time to decision
272 days90th percentile
17clearances measured

FDA profile

Official device name
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Device class
Class II (moderate risk)
Regulation
21 CFR 866.6010
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2009: 7 · 2011: 6 · 2012: 6 · 2013: 11 · 2018: 18 · 2019: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Elecsys AFP (K220176)Roche Diagnostics2022-09-15
VITROS AFP (K213626)Ortho Clinical Diagnostics2022-06-15
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 (K090236)Siemens Healthcare Diagnostics2009-04-27
OLYMPUS AFP - ALPHA-FETOPROTEIN (K081709)Olympus Life Science Research Europa GmbH (Europa)2009-03-16
VIDAS AFP ASSAY (K080017)bioMerieux, Inc.2008-09-26
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 (K071597)Dade Behring, Inc.2008-06-04
ST AIA-PACK AFP ENZYME IMMUNOASSAY (K023894)Tosoh Medics, Inc.2002-12-17
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020807)Bayer Diagnostics Corp.2002-10-01
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (K020806)Bayer Corp.2002-03-27
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (K990138)Diagnostic Systems Laboratories, Inc.1999-06-21
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY (K983031)Ortho-Clinical Diagnostics, Inc.1998-12-18
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 (K983263)Diagnostic Products Corp.1998-12-07
ELECSYS AFP (K981282)Roche Diagnostics GmbH1998-05-01
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (K981354)Beckman Instruments, Inc.1998-05-01
ELECSYS AFP (K973351)Boehringer Mannheim Corp.1997-11-21
AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K972462)Bayer Corp.1997-09-22
TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS (K851891)Richard Scott Elliott1985-07-19

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Every clearance here is in the API, with alerts when new ones post.