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FDA 510(k)

ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY

K-Number: K031857 · 2003-09-04

ApplicantBayer Diagnostics Corp.
Decision Date2003-09-04
Product CodeDEM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Diagnostics Corp.. It received FDA 510(k) clearance on 2003-09-04 under 510(k) number K031857. The device is classified under product code DEM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY?

ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY is a medical device that received FDA 510(k) clearance on 2003-09-04. The listed applicant is Bayer Diagnostics Corp.. The 510(k) number is K031857.

When did ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY receive FDA 510(k) clearance?

ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY received FDA 510(k) clearance on 2003-09-04, under 510(k) number K031857.

Who is the listed applicant for ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY?

The FDA 510(k) record lists Bayer Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY?

The FDA product code for ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY is DEM.

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Other records listing Bayer Diagnostics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K033379BAYER SPECIAL CHEMISTRY CONTROLSK033380BAYER SPECIAL CHEMISTRY CALIBRATORSK033007BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEMK022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMK030452BAYER LIGAND PLUS 1, 2, 3 CONTROLSK023840ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650

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Related Devices (Code: DEM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123256HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUSThe Binding Site Group , Ltd.K063610DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGHDade Behring, Inc.K053072N ANTISERA TO HUMAN ALPHA1-ANTITRYPSINDade Behring, Inc.K052819VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K050596QUANTIA A1-ATBiokit, S.A.K011663MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLSThe Binding Site, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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