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FDA 510(k)

TXOCELL-IHA REAGENT SYSTEM

K-Number: K790460 · 1979-05-25

ApplicantCalbiochem-Behring Corp.
Decision Date1979-05-25
Product CodeGMM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TXOCELL-IHA REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1979-05-25 under 510(k) number K790460. 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 TXOCELL-IHA REAGENT SYSTEM?

TXOCELL-IHA REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1979-05-25. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K790460.

When did TXOCELL-IHA REAGENT SYSTEM receive FDA 510(k) clearance?

TXOCELL-IHA REAGENT SYSTEM received FDA 510(k) clearance on 1979-05-25, under 510(k) number K790460.

Who is the listed applicant for TXOCELL-IHA REAGENT SYSTEM?

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

What is the FDA product code for TXOCELL-IHA REAGENT SYSTEM?

The FDA product code for TXOCELL-IHA REAGENT SYSTEM is GMM.

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Other records listing Calbiochem-Behring Corp. as applicant

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Related Devices (Code: GMM)

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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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