COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE— 510(k) K885076

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K885076 for COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE, Substantially Equivalent on 1988-12-30. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1988-12-08
Decision date: 1988-12-30
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.