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FDA 510(k)

HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT

K-Number: K851976 · 1985-10-16

ApplicantSi Sero-Immuno Diagnostics, Inc.
Decision Date1985-10-16
Product CodeGMM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Si Sero-Immuno Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K851976. The device is classified under product code GMM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT?

HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Si Sero-Immuno Diagnostics, Inc.. The 510(k) number is K851976.

When did HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT receive FDA 510(k) clearance?

HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT received FDA 510(k) clearance on 1985-10-16, under 510(k) number K851976.

Who is the listed applicant for HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT?

The FDA 510(k) record lists Si Sero-Immuno Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT?

The FDA product code for HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT is GMM.

Related Clinical Trials

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.

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Other records listing Si Sero-Immuno Diagnostics, Inc. 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.

K851977HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT

Related Devices (Code: GMM)

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.

K981263TOXOGENInstrumentation Laboratory COK952818ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDIIPyramid Biological Corp.K851977HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KITSi Sero-Immuno Diagnostics, Inc.K830870POLYCHACO INDIRECT HEMAGGLUTINATIONParasitic Disease ConsultantsK802452TOXOTEST-MT EIKEN KITSyn-Kit, Inc.K790460TXOCELL-IHA REAGENT SYSTEMCalbiochem-Behring Corp.

Official Source

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

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