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)

DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM

K-Number: K981306 · 1998-09-29

ApplicantDiamedix Corp.
Decision Date1998-09-29
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIAMEDIX IS-HSV 1 & 2 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 1998-09-29 under 510(k) number K981306. 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 DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM?

DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-09-29. The listed applicant is Diamedix Corp.. The 510(k) number is K981306.

When did DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM receive FDA 510(k) clearance?

DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM received FDA 510(k) clearance on 1998-09-29, under 510(k) number K981306.

Who is the listed applicant for DIAMEDIX IS-HSV 1 & 2 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 DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM?

The FDA product code for DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM 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 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

View all 68 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.

↑