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FDA 510(k)

ECHO TYPE 16 CF ANTIGEN

K-Number: K853156 · 1985-11-07

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

Device Summary

ECHO TYPE 16 CF ANTIGEN 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 K853156. The device is classified under product code GNK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHO TYPE 16 CF ANTIGEN?

ECHO TYPE 16 CF ANTIGEN 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 K853156.

When did ECHO TYPE 16 CF ANTIGEN receive FDA 510(k) clearance?

ECHO TYPE 16 CF ANTIGEN received FDA 510(k) clearance on 1985-11-07, under 510(k) number K853156.

Who is the listed applicant for ECHO TYPE 16 CF ANTIGEN?

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 ECHO TYPE 16 CF ANTIGEN?

The FDA product code for ECHO TYPE 16 CF ANTIGEN is GNK.

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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: GNK)

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.

K853157ECHO TYPE 11 CF ANTIGENHillcrest BiologicalsK853165ECHO TYPE 30 CF ANTIGENHillcrest Biologicals

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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