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FDA 510(k)

HERPESIVIRUS TEST (TYPE L & 2)

K-Number: K770092 · 1977-03-01

ApplicantMicrobiological Research Corp.
Decision Date1977-03-01
Product CodeGOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HERPESIVIRUS TEST (TYPE L & 2) is the device name listed in this FDA 510(k) record. The listed applicant is Microbiological Research Corp.. It received FDA 510(k) clearance on 1977-03-01 under 510(k) number K770092. The device is classified under product code GOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERPESIVIRUS TEST (TYPE L & 2)?

HERPESIVIRUS TEST (TYPE L & 2) is a medical device that received FDA 510(k) clearance on 1977-03-01. The listed applicant is Microbiological Research Corp.. The 510(k) number is K770092.

When did HERPESIVIRUS TEST (TYPE L & 2) receive FDA 510(k) clearance?

HERPESIVIRUS TEST (TYPE L & 2) received FDA 510(k) clearance on 1977-03-01, under 510(k) number K770092.

Who is the listed applicant for HERPESIVIRUS TEST (TYPE L & 2)?

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

What is the FDA product code for HERPESIVIRUS TEST (TYPE L & 2)?

The FDA product code for HERPESIVIRUS TEST (TYPE L & 2) is GOL.

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Other records listing Microbiological Research 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.

K883011MRI NEO-TRYP TRYPSIN RIAK861120THE GOLDEN QUAD TEST (HSV)K861122THE GOLDEN QUAD TEST (TOXO)K861123THE GOLDEN QUAD TEST (CMV)K861121THE GOLDEN QUAD TEST (EBV)K860450THE CMV-IGM TEST

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Related Devices (Code: GOL)

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.

K841174RUBELLA ANTIBODY FLUOROIMMUNOASSAYIntl. Diagnostic TechnologyK834032RUBAQUICK DIAGNOSTIC KITAbbott LaboratoriesK810309RUBELLA ANTIBODIES TEST REAGENTSCalbiochem-Behring Corp.K802508RUBELISA IGM TEST KITM.A. BioproductsK802102RUBELLA ELISA REAGENTS RUBELLA IGG ANTICalbiochem-Behring Corp.K802339EIA RUBELLA-GBeckman Instruments, 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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