BIOTROL BILIRUBIN C & T CONTROL— 510(k) K905280

Substantially Equivalent

Biotrol, USA, Inc.

FDA 510(k) clearance K905280 for BIOTROL BILIRUBIN C & T CONTROL, Substantially Equivalent on 1991-02-04. Applicant: Biotrol, USA, Inc..

Clearance details

Applicant: Biotrol, USA, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1990-11-23
Decision date: 1991-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westchester, PA, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.