Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HSV-2 IGM ELISA TEST

K-Number: K910953 · 1991-05-28

ApplicantGull Laboratories, Inc.
Decision Date1991-05-28
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HSV-2 IGM 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 1991-05-28 under 510(k) number K910953. The device is classified under product code LGC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HSV-2 IGM ELISA TEST?

HSV-2 IGM ELISA TEST is a medical device that received FDA 510(k) clearance on 1991-05-28. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K910953.

When did HSV-2 IGM ELISA TEST receive FDA 510(k) clearance?

HSV-2 IGM ELISA TEST received FDA 510(k) clearance on 1991-05-28, under 510(k) number K910953.

Who is the listed applicant for HSV-2 IGM 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 HSV-2 IGM ELISA TEST?

The FDA product code for HSV-2 IGM ELISA TEST is LGC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 57 devices →

Related Devices (Code: LGC)

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.

K033059HERPES GROUP IGGTrinity Biotech, Inc.K010878MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6Diagnostic Products Corp.K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEMDiamedix Corp.K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GMrl DiagnosticsK992166THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K983886POCKIT HSV 2 RAPID TESTDiagnology , Ltd.

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.

↑