ACS ULTRA-1 THROMBOPLASTIN— 510(k) K913249

Substantially Equivalent

Analytical Control Systems, Inc.

FDA 510(k) clearance K913249 for ACS ULTRA-1 THROMBOPLASTIN, Substantially Equivalent on 1991-12-04. Applicant: Analytical Control Systems, Inc..

Clearance details

Applicant: Analytical Control Systems, Inc.
Product code: Code GJS
Advisory panel: Hematology
Date received: 1991-07-22
Decision date: 1991-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fishers, IN, US

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Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

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.