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FDA 510(k)

TOXHA TEST

K-Number: K771560 · 1977-09-15

ApplicantBurroughs Wellcome Co.
Decision Date1977-09-15
Product CodeGMM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXHA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Burroughs Wellcome Co.. It received FDA 510(k) clearance on 1977-09-15 under 510(k) number K771560. 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 TOXHA TEST?

TOXHA TEST is a medical device that received FDA 510(k) clearance on 1977-09-15. The listed applicant is Burroughs Wellcome Co.. The 510(k) number is K771560.

When did TOXHA TEST receive FDA 510(k) clearance?

TOXHA TEST received FDA 510(k) clearance on 1977-09-15, under 510(k) number K771560.

Who is the listed applicant for TOXHA TEST?

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

What is the FDA product code for TOXHA TEST?

The FDA product code for TOXHA TEST is GMM.

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Other records listing Burroughs Wellcome Co. 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.

K820069WELLCOGEN GROUP BK813508SAC-CELK810215DAC-CEL HCGK810214DAC-CEL DIAGNATALK810212DAC-CEL T3 UPTAKEK810213DAC-CEL TSH

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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.K851976HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KITSi Sero-Immuno Diagnostics, Inc.K830870POLYCHACO INDIRECT HEMAGGLUTINATIONParasitic Disease ConsultantsK802452TOXOTEST-MT EIKEN KITSyn-Kit, Inc.

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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