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FDA 510(k)

SPQ(TM) ANTIBODY REAGENT SET II FOR AAT

K-Number: K890415 · 1989-02-17

ApplicantAtlantic Antibodies
Decision Date1989-02-17
Product CodeDEM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPQ(TM) ANTIBODY REAGENT SET II FOR AAT is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Antibodies. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K890415. 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 SPQ(TM) ANTIBODY REAGENT SET II FOR AAT?

SPQ(TM) ANTIBODY REAGENT SET II FOR AAT is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Atlantic Antibodies. The 510(k) number is K890415.

When did SPQ(TM) ANTIBODY REAGENT SET II FOR AAT receive FDA 510(k) clearance?

SPQ(TM) ANTIBODY REAGENT SET II FOR AAT received FDA 510(k) clearance on 1989-02-17, under 510(k) number K890415.

Who is the listed applicant for SPQ(TM) ANTIBODY REAGENT SET II FOR AAT?

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

What is the FDA product code for SPQ(TM) ANTIBODY REAGENT SET II FOR AAT?

The FDA product code for SPQ(TM) ANTIBODY REAGENT SET II FOR AAT is DEM.

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Other records listing Atlantic Antibodies 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.

K892526SPQ TM TEST SYSTEM II FOR CRPK891154SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO BK890563SPQ(TM) ANTIBODY REAGENT SET II FOR TRFK890561SPQ(TM) ANTIBODY REAGENT SET II FOR IGMK890416SPQ(TM) ANTIBODY REAGENT SET II FOR IGGK890562SPQ(TM) ANTIBODY REAGENT SET II FOR HPT

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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.K031857ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYBayer Diagnostics Corp.

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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