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FDA 510(k)

HSV IDR

K-Number: K854974 · 1986-03-07

ApplicantGenus Diagnostics
Decision Date1986-03-07
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HSV IDR is the device name listed in this FDA 510(k) record. The listed applicant is Genus Diagnostics. It received FDA 510(k) clearance on 1986-03-07 under 510(k) number K854974. 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 HSV IDR?

HSV IDR is a medical device that received FDA 510(k) clearance on 1986-03-07. The listed applicant is Genus Diagnostics. The 510(k) number is K854974.

When did HSV IDR receive FDA 510(k) clearance?

HSV IDR received FDA 510(k) clearance on 1986-03-07, under 510(k) number K854974.

Who is the listed applicant for HSV IDR?

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

What is the FDA product code for HSV IDR?

The FDA product code for HSV IDR is GQN.

Other records listing Genus Diagnostics 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.

K852206HEP-2 GENCELLSK852204MCCOY GENCELLSK852205RMK GENCELLS CULTURE SYSTEMK851928HEK GENCELLSK851927VERO GENCELLSK851561WI-38 GENCELLS

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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.K964874HSV-1 ANTIGEN CONTROL SLIDESViral Antigens, Inc.K971101HSV-2 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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