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FDA 510(k)

SERAQUEST VZV IGG

K-Number: K972295 · 1997-11-05

ApplicantQuest Intl., Inc.
Decision Date1997-11-05
Product CodeLFY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERAQUEST VZV 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 1997-11-05 under 510(k) number K972295. The device is classified under product code LFY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERAQUEST VZV IGG?

SERAQUEST VZV IGG is a medical device that received FDA 510(k) clearance on 1997-11-05. The listed applicant is Quest Intl., Inc.. The 510(k) number is K972295.

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

SERAQUEST VZV IGG received FDA 510(k) clearance on 1997-11-05, under 510(k) number K972295.

Who is the listed applicant for SERAQUEST VZV 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 VZV IGG?

The FDA product code for SERAQUEST VZV IGG is LFY.

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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: LFY)

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.

K231214LIAISON VZV IgG HT, LIAISON Control VZV IgG HTDiaSorin, Inc.K070317ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEMZeus Scientific, Inc.K061820DIASORIN LIAISON VZV IGGDiaSorin, Inc.K051484ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.Zeus Scientific, Inc.K984181THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEMZeus Scientific, Inc.K981867IS-VZU IGG TEST SYSTEMDiamedix Corp.

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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