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FDA 510(k)

IS-VZU IGG TEST SYSTEM

K-Number: K981867 · 1998-09-28

ApplicantDiamedix Corp.
Decision Date1998-09-28
Product CodeLFY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IS-VZU IGG TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1998-09-28 under 510(k) number K981867. 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 IS-VZU IGG TEST SYSTEM?

IS-VZU IGG TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-09-28. The listed applicant is Diamedix Corp.. The 510(k) number is K981867.

When did IS-VZU IGG TEST SYSTEM receive FDA 510(k) clearance?

IS-VZU IGG TEST SYSTEM received FDA 510(k) clearance on 1998-09-28, under 510(k) number K981867.

Who is the listed applicant for IS-VZU IGG TEST SYSTEM?

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

What is the FDA product code for IS-VZU IGG TEST SYSTEM?

The FDA product code for IS-VZU IGG TEST SYSTEM is LFY.

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Other records listing Diamedix Corp. 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.

K093101MAGO 4SK021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMK013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM 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.K972295SERAQUEST VZV IGGQuest Intl., 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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