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FDA 510(k)

QUANTIA A1-AT

K-Number: K050596 · 2005-05-13

ApplicantBiokit, S.A.
Decision Date2005-05-13
Product CodeDEM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTIA A1-AT is the device name listed in this FDA 510(k) record. The listed applicant is Biokit, S.A.. It received FDA 510(k) clearance on 2005-05-13 under 510(k) number K050596. 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 QUANTIA A1-AT?

QUANTIA A1-AT is a medical device that received FDA 510(k) clearance on 2005-05-13. The listed applicant is Biokit, S.A.. The 510(k) number is K050596.

When did QUANTIA A1-AT receive FDA 510(k) clearance?

QUANTIA A1-AT received FDA 510(k) clearance on 2005-05-13, under 510(k) number K050596.

Who is the listed applicant for QUANTIA A1-AT?

The FDA 510(k) record lists Biokit, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIA A1-AT?

The FDA product code for QUANTIA A1-AT is DEM.

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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.K031857ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYBayer Diagnostics Corp.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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