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FDA 510(k)

HSV-2 ANTIGEN CONTROL SLIDES

K-Number: K971101 · 1997-07-01

ApplicantViral Antigens, Inc.
Decision Date1997-07-01
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HSV-2 ANTIGEN CONTROL SLIDES is the device name listed in this FDA 510(k) record. The listed applicant is Viral Antigens, Inc.. It received FDA 510(k) clearance on 1997-07-01 under 510(k) number K971101. 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-2 ANTIGEN CONTROL SLIDES?

HSV-2 ANTIGEN CONTROL SLIDES is a medical device that received FDA 510(k) clearance on 1997-07-01. The listed applicant is Viral Antigens, Inc.. The 510(k) number is K971101.

When did HSV-2 ANTIGEN CONTROL SLIDES receive FDA 510(k) clearance?

HSV-2 ANTIGEN CONTROL SLIDES received FDA 510(k) clearance on 1997-07-01, under 510(k) number K971101.

Who is the listed applicant for HSV-2 ANTIGEN CONTROL SLIDES?

The FDA 510(k) record lists Viral Antigens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HSV-2 ANTIGEN CONTROL SLIDES?

The FDA product code for HSV-2 ANTIGEN CONTROL SLIDES is GQN.

Related Clinical Trials

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.

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Other records listing Viral Antigens, Inc. 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.

K964874HSV-1 ANTIGEN CONTROL SLIDESK964870RSV ANTIGEN CONTROL SLIDESK964872VZV ANTIGEN CONTROL SLIDESK964875CMV ANTIGEN CONTROL SLIDESK903882VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG

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.K960578ELVIS HSV GOLDDiagnostic Hybrids, 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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