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FDA 510(k)

VZV IGG ELISA TEST

K-Number: K941046 · 1995-08-24

ApplicantGull Laboratories, Inc.
Decision Date1995-08-24
Product CodeLFY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VZV IGG ELISA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1995-08-24 under 510(k) number K941046. 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 VZV IGG ELISA TEST?

VZV IGG ELISA TEST is a medical device that received FDA 510(k) clearance on 1995-08-24. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K941046.

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

VZV IGG ELISA TEST received FDA 510(k) clearance on 1995-08-24, under 510(k) number K941046.

Who is the listed applicant for VZV IGG ELISA TEST?

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

What is the FDA product code for VZV IGG ELISA TEST?

The FDA product code for VZV IGG ELISA TEST is LFY.

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Other records listing Gull Laboratories, 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.

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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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