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FDA 510(k)

ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

K-Number: K952818 · 1995-11-20

ApplicantPyramid Biological Corp.
Decision Date1995-11-20
Product CodeGMM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII is the device name listed in this FDA 510(k) record. The listed applicant is Pyramid Biological Corp.. It received FDA 510(k) clearance on 1995-11-20 under 510(k) number K952818. 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 ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII?

ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII is a medical device that received FDA 510(k) clearance on 1995-11-20. The listed applicant is Pyramid Biological Corp.. The 510(k) number is K952818.

When did ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII receive FDA 510(k) clearance?

ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII received FDA 510(k) clearance on 1995-11-20, under 510(k) number K952818.

Who is the listed applicant for ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII?

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

What is the FDA product code for ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII?

The FDA product code for ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII is GMM.

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Other records listing Pyramid Biological Corp. 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.

K964675H.PYLORI CONTROLSK962399HEPATITIS NEGATIVE CONTROLK961317SYPHILIS IGM HUMAN SERUM CONTROLSK960493SYPHILIS IGG HUMAN SERUM CONTROLSK954515ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLAK953826ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA

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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 COK851977HEM 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.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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