510(k) K963934— ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329

Substantially Equivalent

Bio-Rad Laboratories, Inc.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 1996-10-01
Decision date: 1996-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Adverse events under product code MMI

product code MMI

Injury: 172
Malfunction: 3,762
Total: 3,934

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.