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FDA Product Code

FDA Product Code GIT — Clearance Directory

Device Class
Class II
Assigned Panel
Hematology
21 CFR Citation
864.7925

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K890051 BIOTRACK APTT CONTROLS Biotrack, Inc. 1989-02-23 Traditional PDF ↗
K881999 PLATELIN(R) EXCEL L Organon Teknika Corp. 1988-08-17 Traditional PDF ↗
K880711 CLP 0.02 M CALCIUM CHLORIDE SOLUTION. Creative Laboratory Products, Inc. 1988-03-18 Traditional PDF ↗
K820450 THROMBOSCREEN Pacific Hemostasis 1982-03-26 Traditional PDF ↗

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