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FDA 510(k)

HSV IGM TEST

K-Number: K830865 · 1983-07-18

ApplicantGull Laboratories, Inc.
Decision Date1983-07-18
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HSV 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 1983-07-18 under 510(k) number K830865. The device is classified under product code GQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HSV IGM TEST?

HSV IGM TEST is a medical device that received FDA 510(k) clearance on 1983-07-18. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K830865.

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

HSV IGM TEST received FDA 510(k) clearance on 1983-07-18, under 510(k) number K830865.

Who is the listed applicant for HSV 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 HSV IGM TEST?

The FDA product code for HSV IGM TEST is GQL.

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: GQL)

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.

K091753ELVIS HSV ID AND D3 TYPING TEST SYSTEMDiagnostic Hybrids, Inc.K081527LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KITMillipore CorporationK984120THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K984135THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1Stellar Bio Systems, Inc.K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGCalifornia Integrated Diagnostics, 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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