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FDA 510(k)

MICROTRAK HSV 1 & 2 DIRECT SPECIMAN

K-Number: K841190 · 1985-01-18

ApplicantSyva Co.
Decision Date1985-01-18
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROTRAK HSV 1 & 2 DIRECT SPECIMAN is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1985-01-18 under 510(k) number K841190. 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 MICROTRAK HSV 1 & 2 DIRECT SPECIMAN?

MICROTRAK HSV 1 & 2 DIRECT SPECIMAN is a medical device that received FDA 510(k) clearance on 1985-01-18. The listed applicant is Syva Co.. The 510(k) number is K841190.

When did MICROTRAK HSV 1 & 2 DIRECT SPECIMAN receive FDA 510(k) clearance?

MICROTRAK HSV 1 & 2 DIRECT SPECIMAN received FDA 510(k) clearance on 1985-01-18, under 510(k) number K841190.

Who is the listed applicant for MICROTRAK HSV 1 & 2 DIRECT SPECIMAN?

The FDA 510(k) record lists Syva Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROTRAK HSV 1 & 2 DIRECT SPECIMAN?

The FDA product code for MICROTRAK HSV 1 & 2 DIRECT SPECIMAN 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 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

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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