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FDA 510(k)

VZV IGM TEST

K-Number: K911301 · 1991-07-17

ApplicantGull Laboratories, Inc.
Decision Date1991-07-17
Product CodeGQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VZV IGM 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 1991-07-17 under 510(k) number K911301. The device is classified under product code GQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VZV IGM TEST?

VZV IGM TEST is a medical device that received FDA 510(k) clearance on 1991-07-17. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K911301.

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

VZV IGM TEST received FDA 510(k) clearance on 1991-07-17, under 510(k) number K911301.

Who is the listed applicant for VZV IGM 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 IGM TEST?

The FDA product code for VZV IGM TEST is GQX.

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.

K983541HSV 1+2 IGG ELISA TESTK971857MUMPS IGG ELISA TESTYK962343TOXO IGG ELISA TESTK935730EBNA IGG ELISA TESTK940093EBV-EA(D) IGG ELISA TESTK941046VZV IGG ELISA TEST

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Related Devices (Code: GQX)

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.

K951799VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAYLight DiagnosticsK883427VIRGO(R) VZV-IGG ELISAElectro-Nucleonics, Inc.K875358VZV TESTGull Laboratories, Inc.K863317ENZYGNOST ANTI-VZV IGG TESTBehring Diagnostics, Inc.K853540FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGYIdt, A Division of Whittaker M.A. BioproductsK852930VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTROMicrobix Biosystems, 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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