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FDA 510(k)

HERPES SIMPLEX GROUP CF ANTIGEN

K-Number: K850609 · 1985-05-09

ApplicantHillcrest Biologicals
Decision Date1985-05-09
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HERPES SIMPLEX GROUP 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 1985-05-09 under 510(k) number K850609. The device is classified under product code GQN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERPES SIMPLEX GROUP CF ANTIGEN?

HERPES SIMPLEX GROUP CF ANTIGEN is a medical device that received FDA 510(k) clearance on 1985-05-09. The listed applicant is Hillcrest Biologicals. The 510(k) number is K850609.

When did HERPES SIMPLEX GROUP CF ANTIGEN receive FDA 510(k) clearance?

HERPES SIMPLEX GROUP CF ANTIGEN received FDA 510(k) clearance on 1985-05-09, under 510(k) number K850609.

Who is the listed applicant for HERPES SIMPLEX GROUP 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 HERPES SIMPLEX GROUP CF ANTIGEN?

The FDA product code for HERPES SIMPLEX GROUP CF ANTIGEN is GQN.

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Other records listing Hillcrest Biologicals as applicant

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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: GQN)

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.

K070265DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000Diagnostic Hybrids, Inc.K063798DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000Diagnostic Hybrids, Inc.K991880LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAYLight DiagnosticsK971662ELVIS HSV ID/TYPING TEST SYSTEMDiagnostic Hybrids, Inc.K971101HSV-2 ANTIGEN CONTROL SLIDESViral Antigens, Inc.K964874HSV-1 ANTIGEN CONTROL SLIDESViral Antigens, 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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