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FDA 510(k)

SERAQUEST HSV IGG

K-Number: K963282 · 1997-01-22

ApplicantQuest Intl., Inc.
Decision Date1997-01-22
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERAQUEST HSV IGG is the device name listed in this FDA 510(k) record. The listed applicant is Quest Intl., Inc.. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K963282. 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 SERAQUEST HSV IGG?

SERAQUEST HSV IGG is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Quest Intl., Inc.. The 510(k) number is K963282.

When did SERAQUEST HSV IGG receive FDA 510(k) clearance?

SERAQUEST HSV IGG received FDA 510(k) clearance on 1997-01-22, under 510(k) number K963282.

Who is the listed applicant for SERAQUEST HSV IGG?

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

What is the FDA product code for SERAQUEST HSV IGG?

The FDA product code for SERAQUEST HSV IGG is LGC.

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Other records listing Quest Intl., 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.

K091260SERAQUEST EBV EA-D IGG TESTK033915MODIFICATION TO SERAQUEST EB VCA IGGK033780MODIFICATION TO SERAQUEST VCA IGMK023593SERAQUEST ANTI-THYROID PEROXIDASE (TPO)K023592SERAQUEST ANTI-THYROGLOBULINK003069ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM

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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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