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FDA Product Code

FDA Product Code JMA — Clearance Directory

Device Class
Class I
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.1095

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K931523 QUANTIMETRIX C-CLEAR(TM) Quantimetrix Corp. 1993-06-25 Traditional PDF ↗
K830978 HELENA BIOSTRIP A Helena Laboratories 1983-05-13 Traditional PDF ↗
K822709 URITEST 9, INLAB REAGENT STRIPS URINALY Laprol Scientific, Inc. 1983-01-28 Traditional PDF ↗

Product code JMA · Class I · Clinical Chemistry. Data: openFDA.