THROMBOSTIN IFA*— 510(k) K885107

Substantially Equivalent

Investigacion Farmaceutica S.A. DE C.V.

FDA 510(k) clearance K885107 for THROMBOSTIN IFA*, Substantially Equivalent on 1989-06-23. Applicant: Investigacion Farmaceutica S.A. DE C.V..

Clearance details

Applicant: Investigacion Farmaceutica S.A. DE C.V.
Product code: Code GJS
Advisory panel: Hematology
Date received: 1988-12-12
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mexico, MX

Download summary PDF View on FDA.gov ↗

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.