AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK— 510(k) K944697

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K944697 for AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK, Substantially Equivalent on 1995-02-22. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1994-09-23
Decision date: 1995-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.