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FDA Product Code

FDA Product Code QKE — Clearance Directory

Device Class
Class I
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.1620

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
K191462 Proov Test Mfb Fertility, Inc. 2020-02-27 Traditional PDF ↗

Product code QKE · Class I · Clinical Chemistry. Data: openFDA.