Atlas FDA

DEM

30 FDA 510(k) clearances · Product code

80 daysmedian time to decision
209 days90th percentile
30clearances measured

FDA profile

Official device name
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5130
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS (K123256)The Binding Site Group , Ltd.2013-07-03
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH (K063610)Dade Behring, Inc.2007-01-11
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN (K053072)Dade Behring, Inc.2006-03-28
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III (K052819)Ortho-Clinical Diagnostics, Inc.2005-12-23
QUANTIA A1-AT (K050596)Biokit, S.A.2005-05-13
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY (K031857)Bayer Diagnostics Corp.2003-09-04
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS (K011663)The Binding Site, Ltd.2001-07-30
TINA-QUANT ALPHA-1 ANTITRYPSIN (K010978)Rochdiag2001-05-18
K-ASSAY ALPHA-1 AT (K993444)Kamiya Biomedical Co.1999-11-24
TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY (K972640)Boehringer Mannheim Corp.1998-01-09
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING (K973389)Ventana Medical Systems, Inc.1997-10-03
CHEMMATE LAMBDA (K973392)Ventana Medical Systems, Inc.1997-10-03
CHEMMATE KAPPA (K973391)Ventana Medical Systems, Inc.1997-10-03
CHEMMATE L26 (CD20) (K973390)Ventana Medical Systems, Inc.1997-10-03
N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT (K965100)Crestat Diagnostics, Inc.1997-07-14
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) (K964766)Beckman Instruments, Inc.1997-04-25
VENTANA NEGATIVE CONTROL REAGENT (K931979)Ventana Medical Systems, Inc.1994-03-30
IL TEST ALPHA-1-ANTITRYPSIN (AAT) (K920005)Instrumentation Laboratory CO1992-07-29
ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT (K913666)The Binding Site, Ltd.1991-12-09
SPQ(TM) ANTIBODY REAGENT SET II FOR AAT (K890415)Atlantic Antibodies1989-02-17
ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM (K882446)Technicon Instruments Corp.1988-07-08
QM2/QM300 CONTROL B PACK (K875283)Kallestad Diag, A Div. of Erbamont, Inc.1988-02-10
QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK (K875281)Kallestad Diag, A Div. of Erbamont, Inc.1988-02-10
SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN (K850587)Applications Lab1985-03-14
J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO (K801669)J.T. Baker Chemical Co.1980-09-16
GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN (K791605)Protos Laboratories1979-09-04
RID SYSTEM-(ACP) TEST (K781408)Icl Scientific1978-08-21
RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT (K772080)Gelman Instrument Co.1978-02-03
LAS-R HUMAN ALPHA, ANTITRYPSIN TEST (K760916)Hyland Therapeutic Div., Travenol Laboratories1976-11-16
TEST, STREP, LATEX SLIDE (K760034)Gamma Biologicals, Inc.1976-08-11

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