RADIAS GALT TEST— 510(k) K961432

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K961432 for RADIAS GALT TEST, Substantially Equivalent on 1996-10-28. Applicant: Bio-Rad.

Clearance details

Applicant: Bio-Rad
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1996-04-15
Decision date: 1996-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, 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.