CLARIT(TM)— 510(k) K945353

Substantially Equivalent

Advanced Biomedical Methods, Inc.

FDA 510(k) clearance K945353 for CLARIT(TM), Substantially Equivalent on 1994-12-09. Applicant: Advanced Biomedical Methods, Inc..

Clearance details

Applicant: Advanced Biomedical Methods, Inc.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 1994-10-20
Decision date: 1994-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, US

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Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.