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FDA 510(k)

HERPES

K-Number: K811021 · 1981-11-05

ApplicantImmuno-Diagnostic Products, Inc.
Decision Date1981-11-05
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HERPES is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Diagnostic Products, Inc.. It received FDA 510(k) clearance on 1981-11-05 under 510(k) number K811021. 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?

HERPES is a medical device that received FDA 510(k) clearance on 1981-11-05. The listed applicant is Immuno-Diagnostic Products, Inc.. The 510(k) number is K811021.

When did HERPES receive FDA 510(k) clearance?

HERPES received FDA 510(k) clearance on 1981-11-05, under 510(k) number K811021.

Who is the listed applicant for HERPES?

The FDA 510(k) record lists Immuno-Diagnostic Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HERPES?

The FDA product code for HERPES is GQN.

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Other records listing Immuno-Diagnostic Products, Inc. as applicant

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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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