VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA— 510(k) K930849

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K930849 for VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA, Substantially Equivalent on 1993-04-20. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1993-02-18
Decision date: 1993-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

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.