ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505— 510(k) K980173

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K980173 for ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505, Substantially Equivalent on 1998-03-18. Applicant: Beckman Instruments, Inc..

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1998-01-20
Decision date: 1998-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.