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510(k) K920005

Device
Il Test Alpha-1-antitrypsin (aat)
Applicant
INSTRUMENTATION LABORATORY CO.
510(k) number
K920005
Product code
DEM
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-29
Date received
1992-01-02
Regulation
866.5130
Classification name
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GABRIEL J MURACA
Address
113 Hartwell Ave. P.O. Box 9113 Lexington MA US 02173 02173

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DEM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123256HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUSThe Binding Site Group , Ltd.2013-07-03
K063610DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGHDade Behring, Inc.2007-01-11
K053072N ANTISERA TO HUMAN ALPHA1-ANTITRYPSINDade Behring, Inc.2006-03-28
K052819VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.2005-12-23
K050596QUANTIA A1-ATBiokit, S.A.2005-05-13
K031857ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYBayer Diagnostics Corp.2003-09-04
K011663MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLSThe Binding Site, Ltd.2001-07-30
K010978TINA-QUANT ALPHA-1 ANTITRYPSINRochdiag2001-05-18
K993444K-ASSAY ALPHA-1 ATKamiya Biomedical Co.1999-11-24
K972640TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAYBoehringer Mannheim Corp.1998-01-09
K973392CHEMMATE LAMBDAVentana Medical Systems, Inc.1997-10-03
K973391CHEMMATE KAPPAVentana Medical Systems, Inc.1997-10-03
K973390CHEMMATE L26 (CD20)Ventana Medical Systems, Inc.1997-10-03
K973389CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAININGVentana Medical Systems, Inc.1997-10-03
K965100N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KITCrestat Diagnostics, Inc.1997-07-14