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FDA 510(k)

HERPES GROUP IGG ELISA TEST SYSTEM

K-Number: K963645 · 1997-02-04

ApplicantArmkel, LLC
Decision Date1997-02-04
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HERPES GROUP IGG ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1997-02-04 under 510(k) number K963645. The device is classified under product code LGC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERPES GROUP IGG ELISA TEST SYSTEM?

HERPES GROUP IGG ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Armkel, LLC. The 510(k) number is K963645.

When did HERPES GROUP IGG ELISA TEST SYSTEM receive FDA 510(k) clearance?

HERPES GROUP IGG ELISA TEST SYSTEM received FDA 510(k) clearance on 1997-02-04, under 510(k) number K963645.

Who is the listed applicant for HERPES GROUP IGG ELISA TEST SYSTEM?

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 HERPES GROUP IGG ELISA TEST SYSTEM?

The FDA product code for HERPES GROUP IGG ELISA TEST SYSTEM is LGC.

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Other records listing Armkel, LLC as applicant

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Related Devices (Code: LGC)

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.

K033059HERPES GROUP IGGTrinity Biotech, Inc.K010878MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6Diagnostic Products Corp.K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEMDiamedix Corp.K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GMrl DiagnosticsK992166THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K983886POCKIT HSV 2 RAPID TESTDiagnology , Ltd.

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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