Atlas FDA

DER

17 FDA 510(k) clearances · Product code

51 daysmedian time to decision
276 days90th percentile
17clearances measured

FDA profile

Official device name
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5580
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
TINA-QUANT APOLIPOPROTEIN VER.2 (K013249)Roche Diagnostics Corp.2001-11-16
BAYER ADVIA IMS SYSTEM; 200 + 3 (K000921)Bayer Corp.2000-05-18
K-ASSAY APO B (K993354)Kamiya Biomedical Co.1999-10-28
K-ASSAY APO AI (K993345)Kamiya Biomedical Co.1999-10-25
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 (K990594)Roche Diagnostics Corp.1999-04-14
APOLIPOPROTEIN A1 (K983289)Abbott Laboratories1999-01-29
N-ASSAY TIA APO A1/B MULTI CALIBRATOR (K964294)Crestat Diagnostics, Inc.1997-08-01
N-ASSAY TIA APO B TEST KIT (K964296)Crestat Diagnostics, Inc.1997-08-01
N-ASSAY TIA APO A1 TEST KIT (K964292)Crestat Diagnostics, Inc.1997-08-01
ROCHE APOLIPOPROTEIN STANDARD (K910553)Roche Diagnostic Systems, Inc.1991-05-08
UC IMU A (K904125)Eucardio Laboratory, Inc.1990-09-24
QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL (K872078)Solomon Park Research Laboratories1987-06-18
APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 (K854875)Photec Diagnostics, Inc.1986-01-24
APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 (K853048)Photec Diagnostics, Inc.1985-08-28
APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 (K851649)Photec Diagnostics, Inc.1985-06-05
VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN (K840830)Ventrex Laboratories, Inc.1984-05-21
ALERT A,HDL-APOLIPOROTEIN A, TEST KIT (K802610)Hyland Therapeutic Div., Travenol Laboratories1981-01-05

Track DER automatically

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