STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.— 510(k) K894993

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K894993 for STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I., Substantially Equivalent on 1989-10-13. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1989-08-08
Decision date: 1989-10-13
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.