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

FDA 510(k)

Access anti-HAV IgM

K-Number: K251995 · 2026-01-27

ApplicantBeckman Coulter, Inc.
Decision Date2026-01-27
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Access anti-HAV IgM is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2026-01-27 under approval number K251995. 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 Access anti-HAV IgM?

Access anti-HAV IgM is a medical device that received FDA 510(k) clearance on 2026-01-27. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K251995.

When was Access anti-HAV IgM approved by the FDA?

Access anti-HAV IgM received FDA 510(k) clearance on 2026-01-27, under approval number K251995.

What company makes Access anti-HAV IgM?

Access anti-HAV IgM is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access anti-HAV IgM?

The FDA product code for Access anti-HAV IgM is LOL.

Other Devices by Beckman Coulter, Inc.

K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer K162414UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System K153651Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems K172337MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) K172912MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL) K172255MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)

View all 77 devices →

Related Devices (Code: LOL)

K161964ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc. K160650LIAISON HAV IgM, LIAISON Control HAV IgMDiaSorin, Inc. K190428Elecsys Anti-HAV IIRoche Diagnostics K193532LIAISON Anti-HAV AssayDiaSorin, Inc. K210272LIAISON Anti-HAVDiaSorin, Inc. K223403LIAISON Anti-HAV; LIAISON XSDiaSorin, 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.

↑