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FDA 510(k)

POLYCHACO INDIRECT HEMAGGLUTINATION

K-Number: K830870 · 1983-08-12

ApplicantParasitic Disease Consultants
Decision Date1983-08-12
Product CodeGMM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

POLYCHACO INDIRECT HEMAGGLUTINATION is the device name listed in this FDA 510(k) record. The listed applicant is Parasitic Disease Consultants. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K830870. 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 POLYCHACO INDIRECT HEMAGGLUTINATION?

POLYCHACO INDIRECT HEMAGGLUTINATION is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Parasitic Disease Consultants. The 510(k) number is K830870.

When did POLYCHACO INDIRECT HEMAGGLUTINATION receive FDA 510(k) clearance?

POLYCHACO INDIRECT HEMAGGLUTINATION received FDA 510(k) clearance on 1983-08-12, under 510(k) number K830870.

Who is the listed applicant for POLYCHACO INDIRECT HEMAGGLUTINATION?

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

What is the FDA product code for POLYCHACO INDIRECT HEMAGGLUTINATION?

The FDA product code for POLYCHACO INDIRECT HEMAGGLUTINATION 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 Parasitic Disease Consultants 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.

K830869POLYCHACO INDIRECT IMMUNOFLUORESCENCEK831296POLYCHACO FIA-ABS TEST FOR SYPHILIS

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.K802452TOXOTEST-MT EIKEN KITSyn-Kit, Inc.K790460TXOCELL-IHA REAGENT SYSTEMCalbiochem-Behring 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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