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FDA 510(k)

VIROGEN HSV ANTIBODY TEST

K-Number: K871426 · 1987-10-15

ApplicantArmkel, LLC
Decision Date1987-10-15
Product CodeGQO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIROGEN HSV ANTIBODY 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 1987-10-15 under 510(k) number K871426. 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 HSV ANTIBODY TEST?

VIROGEN HSV ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1987-10-15. The listed applicant is Armkel, LLC. The 510(k) number is K871426.

When did VIROGEN HSV ANTIBODY TEST receive FDA 510(k) clearance?

VIROGEN HSV ANTIBODY TEST received FDA 510(k) clearance on 1987-10-15, under 510(k) number K871426.

Who is the listed applicant for VIROGEN HSV ANTIBODY 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 HSV ANTIBODY TEST?

The FDA product code for VIROGEN HSV ANTIBODY TEST is GQO.

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Other records listing Armkel, LLC 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.

K040866FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TESTK030258FIRST RESPONSE PREGNANCY TESTK023405TROJAN MINT TINGLE BRAND LATEX CONDOMSK013433TROJAN PASSION BERRY GELK013614TROJAN CRYSTAL CLEAR LIQUIDK001212TROJAN EXTRA LARGE LATEX CONDOM

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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.

K883282VIRGO HSV-1 IGG ELISAElectro-Nucleonics, Inc.K883281VIRGO HSV-2 IGG ELISAElectro-Nucleonics, Inc.K881261BION HSV1-G OR HSV2-G TEST SYSTEMBion Ent., Ltd.K875366THE DDI SERODOT HERPES IGG TEST KITDisease Detection International, Inc.K861120THE GOLDEN QUAD TEST (HSV)Microbiological Research Corp.K854712VISIBLE-HERPES TM TEST SYSTEMIsolab, 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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