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FDA 510(k)

COXSACKIE B SERIES CF ANTIGENS

K-Number: K850003 · 1985-03-05

ApplicantHillcrest Biologicals
Decision Date1985-03-05
Product CodeGNG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COXSACKIE B SERIES CF ANTIGENS is the device name listed in this FDA 510(k) record. The listed applicant is Hillcrest Biologicals. It received FDA 510(k) clearance on 1985-03-05 under 510(k) number K850003. The device is classified under product code GNG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COXSACKIE B SERIES CF ANTIGENS?

COXSACKIE B SERIES CF ANTIGENS is a medical device that received FDA 510(k) clearance on 1985-03-05. The listed applicant is Hillcrest Biologicals. The 510(k) number is K850003.

When did COXSACKIE B SERIES CF ANTIGENS receive FDA 510(k) clearance?

COXSACKIE B SERIES CF ANTIGENS received FDA 510(k) clearance on 1985-03-05, under 510(k) number K850003.

Who is the listed applicant for COXSACKIE B SERIES CF ANTIGENS?

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 COXSACKIE B SERIES CF ANTIGENS?

The FDA product code for COXSACKIE B SERIES CF ANTIGENS is GNG.

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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: GNG)

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.

K921618COXSACKIE VIRUS B1-B6 CF ANTIGENSVirion (U.S.), 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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