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FDA 510(k)

DIRECT FLUORESCENT ANTIBODY KIT/HERPES

K-Number: K802590 · 1981-02-09

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

Device Summary

DIRECT FLUORESCENT ANTIBODY KIT/HERPES 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 K802590. The device is classified under product code GQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECT FLUORESCENT ANTIBODY KIT/HERPES?

DIRECT FLUORESCENT ANTIBODY KIT/HERPES 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 K802590.

When did DIRECT FLUORESCENT ANTIBODY KIT/HERPES receive FDA 510(k) clearance?

DIRECT FLUORESCENT ANTIBODY KIT/HERPES received FDA 510(k) clearance on 1981-02-09, under 510(k) number K802590.

Who is the listed applicant for DIRECT FLUORESCENT ANTIBODY KIT/HERPES?

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 DIRECT FLUORESCENT ANTIBODY KIT/HERPES?

The FDA product code for DIRECT FLUORESCENT ANTIBODY KIT/HERPES is GQL.

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.

K802526TEST KIT FOR DETECTION OF HERPES SIMPLEXK802527TEST KIT FOR DETECTION OF ANTINUCLEAR

Related Devices (Code: GQL)

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.

K091753ELVIS HSV ID AND D3 TYPING TEST SYSTEMDiagnostic Hybrids, Inc.K081527LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KITMillipore CorporationK984120THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K984135THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1Stellar Bio Systems, Inc.K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGCalifornia Integrated Diagnostics, Inc.

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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