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FDA 510(k)

POLIO TYPE I CF ANTIGEN, & TYPE II, III

K-Number: K853278 · 1985-11-07

ApplicantHillcrest Biologicals
Decision Date1985-11-07
Product CodeGOG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

POLIO TYPE I CF ANTIGEN, & TYPE II, III is the device name listed in this FDA 510(k) record. The listed applicant is Hillcrest Biologicals. It received FDA 510(k) clearance on 1985-11-07 under 510(k) number K853278. The device is classified under product code GOG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLIO TYPE I CF ANTIGEN, & TYPE II, III?

POLIO TYPE I CF ANTIGEN, & TYPE II, III is a medical device that received FDA 510(k) clearance on 1985-11-07. The listed applicant is Hillcrest Biologicals. The 510(k) number is K853278.

When did POLIO TYPE I CF ANTIGEN, & TYPE II, III receive FDA 510(k) clearance?

POLIO TYPE I CF ANTIGEN, & TYPE II, III received FDA 510(k) clearance on 1985-11-07, under 510(k) number K853278.

Who is the listed applicant for POLIO TYPE I CF ANTIGEN, & TYPE II, III?

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

What is the FDA product code for POLIO TYPE I CF ANTIGEN, & TYPE II, III?

The FDA product code for POLIO TYPE I CF ANTIGEN, & TYPE II, III is GOG.

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Other records listing Hillcrest Biologicals 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.

K913617ARBOVIRUS IGG IFA TESTK913618ARBOVIRUS IGM IFA TESTK913906Q FEVER IGG IFA TESTK922374Q FEVER IGM IFA TESTK900206LYME DISEASE IGM ELISAK896594EBV VCA ANTIBODY (IGM)

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Related Devices (Code: GOG)

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.

K071101TRU RSVMeridian Bioscience, Inc.K021172RSV OIAThermo Biostar, 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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