AURAFLEX HCG— 510(k) K945331

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K945331 for AURAFLEX HCG, Substantially Equivalent on 1995-03-20. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1994-11-01
Decision date: 1995-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

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.