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FDA 510(k)

TOXOTEST-MT EIKEN KIT

K-Number: K802452 · 1980-12-18

ApplicantSyn-Kit, Inc.
Decision Date1980-12-18
Product CodeGMM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOTEST-MT EIKEN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1980-12-18 under 510(k) number K802452. 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 TOXOTEST-MT EIKEN KIT?

TOXOTEST-MT EIKEN KIT is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K802452.

When did TOXOTEST-MT EIKEN KIT receive FDA 510(k) clearance?

TOXOTEST-MT EIKEN KIT received FDA 510(k) clearance on 1980-12-18, under 510(k) number K802452.

Who is the listed applicant for TOXOTEST-MT EIKEN KIT?

The FDA 510(k) record lists Syn-Kit, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOXOTEST-MT EIKEN KIT?

The FDA product code for TOXOTEST-MT EIKEN KIT is GMM.

Related Clinical Trials

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Other records listing Syn-Kit, 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K861631SLIDE CULTURE U 'EIKEN'K854819CPR SLIDE EIKENK854820RA 80 EIKENK853276ASO SLIDE EIKENK843753UROPAPER EIKEN GP

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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 ConsultantsK790460TXOCELL-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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