STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY— 510(k) K912241

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K912241 for STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1991-06-20. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1991-05-21
Decision date: 1991-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.