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FDA Product Code

FDA Product Code CEL — Clearance Directory

Device Class
Class I
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.1575

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K905829 DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS Kamiya Biomedical Co. 1991-01-30 Traditional PDF ↗
K884169 DU PONT ANALYST THYROID ROTOR The DU Pont Co. 1989-01-24 Traditional PDF ↗
K801076 WAKO PHOSPHOLIPIDS TEST Wako Pure Chemical Industries, Ltd. 1980-06-30 Traditional PDF ↗

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