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FDA Product Code

FDA Product Code JJB — Clearance Directory

Device Class
Class I
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.1115

510(k) Clearances — 5 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K943436 URINE REAGENT STRIPS-8 PARAMETERS Teco Diagnostics 1995-04-24 Traditional PDF ↗
K943008 BIOSCAN REAGENT STRIPS Genesis Labs, Inc. 1994-08-08 Traditional PDF ↗
K873553 WAKO(TM) PRETEST 8A Wako Chemicals USA, Inc. 1987-09-22 Traditional PDF ↗
K862806 URINE DIAGNOSTIC REAGENT STRIPS Amatech International, Inc. 1986-12-04 Traditional PDF ↗
K833521 REAGENT TESTS STRIP COMBINATIONS Syn-Kit, Inc. 1984-01-11 Traditional PDF ↗

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