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)

VARICELISA TEST KIT

K-Number: K823805 · 1983-05-05

ApplicantM.A. Bioproducts
Decision Date1983-05-05
Product CodeLFY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VARICELISA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is M.A. Bioproducts. It received FDA 510(k) clearance on 1983-05-05 under 510(k) number K823805. 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 VARICELISA TEST KIT?

VARICELISA TEST KIT is a medical device that received FDA 510(k) clearance on 1983-05-05. The listed applicant is M.A. Bioproducts. The 510(k) number is K823805.

When did VARICELISA TEST KIT receive FDA 510(k) clearance?

VARICELISA TEST KIT received FDA 510(k) clearance on 1983-05-05, under 510(k) number K823805.

Who is the listed applicant for VARICELISA TEST KIT?

The FDA 510(k) record lists M.A. Bioproducts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARICELISA TEST KIT?

The FDA product code for VARICELISA TEST KIT is LFY.

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 M.A. Bioproducts 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.

K822883HERPELISA KITK823804MYCOPLASMELISA TEST KITK830045MUMPSELISA TEST KITK830615CYTOMEGELISA STATK821967CHLAMYDELISA TEST KITK821762MEASELISA TEST KIT

View all 12 devices →

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.

↑