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FDA 510(k)

TEST KIT FOR DETECTION OF HERPES SIMPLEX

K-Number: K802526 · 1981-02-09

ApplicantBartels & Stout, Inc.
Decision Date1981-02-09
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TEST KIT FOR DETECTION OF HERPES SIMPLEX is the device name listed in this FDA 510(k) record. The listed applicant is Bartels & Stout, Inc.. It received FDA 510(k) clearance on 1981-02-09 under 510(k) number K802526. 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 TEST KIT FOR DETECTION OF HERPES SIMPLEX?

TEST KIT FOR DETECTION OF HERPES SIMPLEX is a medical device that received FDA 510(k) clearance on 1981-02-09. The listed applicant is Bartels & Stout, Inc.. The 510(k) number is K802526.

When did TEST KIT FOR DETECTION OF HERPES SIMPLEX receive FDA 510(k) clearance?

TEST KIT FOR DETECTION OF HERPES SIMPLEX received FDA 510(k) clearance on 1981-02-09, under 510(k) number K802526.

Who is the listed applicant for TEST KIT FOR DETECTION OF HERPES SIMPLEX?

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

What is the FDA product code for TEST KIT FOR DETECTION OF HERPES SIMPLEX?

The FDA product code for TEST KIT FOR DETECTION OF HERPES SIMPLEX is LGC.

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 Bartels & Stout, 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.

K802590DIRECT FLUORESCENT ANTIBODY KIT/HERPESK802527TEST KIT FOR DETECTION OF ANTINUCLEAR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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