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)

MONOLISA ANTI-HAV IGM EIA

K-Number: K063319 · 2007-05-03

ApplicantBio-Rad Laboratories
Decision Date2007-05-03
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MONOLISA ANTI-HAV IGM EIA is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories. It received FDA 510(k) clearance on 2007-05-03 under 510(k) number K063319. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOLISA ANTI-HAV IGM EIA?

MONOLISA ANTI-HAV IGM EIA is a medical device that received FDA 510(k) clearance on 2007-05-03. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K063319.

When did MONOLISA ANTI-HAV IGM EIA receive FDA 510(k) clearance?

MONOLISA ANTI-HAV IGM EIA received FDA 510(k) clearance on 2007-05-03, under 510(k) number K063319.

Who is the listed applicant for MONOLISA ANTI-HAV IGM EIA?

The FDA 510(k) record lists Bio-Rad Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOLISA ANTI-HAV IGM EIA?

The FDA product code for MONOLISA ANTI-HAV IGM EIA is LOL.

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 Bio-Rad Laboratories 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.

K183446BioPlex 2200 Lyme TotalK180577BioPlex 2200 25-OH Vitamin D KitK170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control SetK170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetK163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakK152679Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

View all 37 devices →

Related Devices (Code: LOL)

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.

K260048Elecsys Anti-HAV IgMRoche DiagnosticsK251995Access anti-HAV IgMBeckman Coulter, Inc.K243846Access anti-HAVBeckman Coulter, Inc.K222850HAVAb IgG IIAbbott LaboratoriesK223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc.K210272LIAISON Anti-HAVDiaSorin, 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.

↑