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FDA Product Code

FDA Product Code GIQ — Clearance Directory

Device Class
Class II
Assigned Panel
Hematology
21 CFR Citation
864.7415

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K955719 SICKLE-2000 Medicus Technologies, Inc. 1996-08-14 Traditional PDF ↗
K942276 QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY Isolab, Inc. 1995-01-20 Traditional PDF ↗
K874429 HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 Hf Scientific, Inc. 1988-02-04 Traditional PDF ↗

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