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FDA 510(k)

H. SIMPLEX VIRUS

K-Number: K843658 · 1985-09-26

ApplicantInstitute Virion , Ltd.
Decision Date1985-09-26
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

H. SIMPLEX VIRUS is the device name listed in this FDA 510(k) record. The listed applicant is Institute Virion , Ltd.. It received FDA 510(k) clearance on 1985-09-26 under 510(k) number K843658. 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 H. SIMPLEX VIRUS?

H. SIMPLEX VIRUS is a medical device that received FDA 510(k) clearance on 1985-09-26. The listed applicant is Institute Virion , Ltd.. The 510(k) number is K843658.

When did H. SIMPLEX VIRUS receive FDA 510(k) clearance?

H. SIMPLEX VIRUS received FDA 510(k) clearance on 1985-09-26, under 510(k) number K843658.

Who is the listed applicant for H. SIMPLEX VIRUS?

The FDA 510(k) record lists Institute Virion , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H. SIMPLEX VIRUS?

The FDA product code for H. SIMPLEX VIRUS is GQN.

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Other records listing Institute Virion , Ltd. 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.

K862814COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNIK843673RESPIRATORY SYNCYTIAL VIRUSK843660IN FLUENZA B VIRUSK843657CYTOMEGALOVIRUSK843662MEASLES VIRUS RUBEOLAK843667PARAINFLUENZA 3

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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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