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FDA 510(k)

VIROGEN HERPES SLIDE TEST

K-Number: K852928 · 1985-10-17

ApplicantArmkel, LLC
Decision Date1985-10-17
Product CodeGQO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIROGEN HERPES SLIDE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1985-10-17 under 510(k) number K852928. The device is classified under product code GQO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIROGEN HERPES SLIDE TEST?

VIROGEN HERPES SLIDE TEST is a medical device that received FDA 510(k) clearance on 1985-10-17. The listed applicant is Armkel, LLC. The 510(k) number is K852928.

When did VIROGEN HERPES SLIDE TEST receive FDA 510(k) clearance?

VIROGEN HERPES SLIDE TEST received FDA 510(k) clearance on 1985-10-17, under 510(k) number K852928.

Who is the listed applicant for VIROGEN HERPES SLIDE TEST?

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

What is the FDA product code for VIROGEN HERPES SLIDE TEST?

The FDA product code for VIROGEN HERPES SLIDE TEST is GQO.

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Other records listing Armkel, LLC as applicant

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Related Devices (Code: GQO)

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.

K883281VIRGO HSV-2 IGG ELISAElectro-Nucleonics, Inc.K883282VIRGO HSV-1 IGG ELISAElectro-Nucleonics, Inc.K881261BION HSV1-G OR HSV2-G TEST SYSTEMBion Ent., Ltd.K875366THE DDI SERODOT HERPES IGG TEST KITDisease Detection International, Inc.K871426VIROGEN HSV ANTIBODY TESTArmkel, LLCK861120THE GOLDEN QUAD TEST (HSV)Microbiological Research Corp.

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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