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FDA 510(k)

HERPES EIA TEST KIT

K-Number: K791397 · 1979-09-24

ApplicantMicrobiological Assoc.
Decision Date1979-09-24
Product CodeGQM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HERPES EIA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Microbiological Assoc.. It received FDA 510(k) clearance on 1979-09-24 under 510(k) number K791397. The device is classified under product code GQM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERPES EIA TEST KIT?

HERPES EIA TEST KIT is a medical device that received FDA 510(k) clearance on 1979-09-24. The listed applicant is Microbiological Assoc.. The 510(k) number is K791397.

When did HERPES EIA TEST KIT receive FDA 510(k) clearance?

HERPES EIA TEST KIT received FDA 510(k) clearance on 1979-09-24, under 510(k) number K791397.

Who is the listed applicant for HERPES EIA TEST KIT?

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

What is the FDA product code for HERPES EIA TEST KIT?

The FDA product code for HERPES EIA TEST KIT is GQM.

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Other records listing Microbiological Assoc. 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.

K792133RUBELISA TEST KITK781549TOXELISA TEST KITK780996RUBELISA TEST KITK781392CYTOMEGILISH TEST KITK781143IMMUNOFLUORESCENCE TEST KITK770764TISSUE CULTURE MEDIA W/HEPES BUFFER

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Related Devices (Code: GQM)

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.

K875367COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMVEnzo Biochem, Inc.K810043GOAT ANTI-HERPES SIMPLEX VIRUS TYPE IVibac 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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