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FDA 510(k)

INDIRECT FLUORO-KIT HSV

K-Number: K830623 · 1983-07-07

ApplicantClinical Sciences, Inc.
Decision Date1983-07-07
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INDIRECT FLUORO-KIT HSV is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1983-07-07 under 510(k) number K830623. 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 INDIRECT FLUORO-KIT HSV?

INDIRECT FLUORO-KIT HSV is a medical device that received FDA 510(k) clearance on 1983-07-07. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K830623.

When did INDIRECT FLUORO-KIT HSV receive FDA 510(k) clearance?

INDIRECT FLUORO-KIT HSV received FDA 510(k) clearance on 1983-07-07, under 510(k) number K830623.

Who is the listed applicant for INDIRECT FLUORO-KIT HSV?

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

What is the FDA product code for INDIRECT FLUORO-KIT HSV?

The FDA product code for INDIRECT FLUORO-KIT HSV is GQL.

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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 CorporationK984135THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K984120THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1Stellar Bio Systems, Inc.K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGCalifornia Integrated Diagnostics, 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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