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FDA Product Code

FDA Product Code OBW — Clearance Directory

Device Class
Class II
Assigned Panel
Hematology
21 CFR Citation
864.5700

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
K062025 ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 Corgenix, Inc. 2007-05-29 Traditional PDF ↗

Product code OBW · Class II · Hematology. Data: openFDA.