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FDA 510(k)

HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT

K-Number: K852931 · 1985-11-12

ApplicantMicrobix Biosystems, Inc.
Decision Date1985-11-12
Product CodeGQO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT is the device name listed in this FDA 510(k) record. The listed applicant is Microbix Biosystems, Inc.. It received FDA 510(k) clearance on 1985-11-12 under 510(k) number K852931. The device is classified under product code GQO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT?

HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Microbix Biosystems, Inc.. The 510(k) number is K852931.

When did HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT receive FDA 510(k) clearance?

HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT received FDA 510(k) clearance on 1985-11-12, under 510(k) number K852931.

Who is the listed applicant for HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT?

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

What is the FDA product code for HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT?

The FDA product code for HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT is GQO.

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Other records listing Microbix Biosystems, 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.

K894262RUBELLA ANTIGEN AND CONTROL ANTIGENK894261TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGENK852930VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTROK852929CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTRK852932MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLTK852933MYCOPLASMA SPP SEROLOGICAL REAGENTS

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Related Devices (Code: GQO)

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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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