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FDA Product Code

FDA Product Code GJE — Clearance Directory

Device Class
Class II
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.1675

510(k) Clearances — 7 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K962596 CUSTOMED BLOOD EXTRACTION KIT Customed, Inc. 1996-09-27 Traditional PDF ↗
K925468 JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT J.J. Skinner, Inc. 1994-04-11 Traditional PDF ↗
K780303 AUTO ISO-FILTER COLLECTION TUBE CAP Bd Becton Dickinson Vacutainer Systems Preanalytic 1978-03-30 Traditional PDF ↗
K771489 RTERIAL BLOOD SAMPLING KIT Bd Becton Dickinson Vacutainer Systems Preanalytic 1977-08-22 Traditional PDF ↗
K771370 ICROTAINEO BRAND TUBE Bd Becton Dickinson Vacutainer Systems Preanalytic 1977-08-03 Traditional PDF ↗
K761177 SODIUM CITRATE Bio/Data Corp. 1977-01-10 Traditional PDF ↗
K760086 TRAY, BLOOD SAMPLING (PULSATOR II) Concord Laboratories, Inc. 1976-07-16 Traditional PDF ↗

Product code GJE · Class II · Clinical Chemistry. Data: openFDA.