STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME— 510(k) K883479

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K883479 for STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME, Substantially Equivalent on 1988-10-25. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1988-08-16
Decision date: 1988-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.