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FDA Product Code

FDA Product Code DAT — Clearance Directory

Device Class
Class II
Assigned Panel
Hematology
21 CFR Citation
864.7340

510(k) Clearances — 2 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K924892 FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM Organon Teknika Corp. 1994-04-21 Traditional PDF ↗
K781103 SPECTRASCAN Medishield, Inc. 1978-09-27 Traditional PDF ↗

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