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FDA Product Code

FDA Product Code LNW — Clearance Directory

Device Class
Class I
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.1550

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K032161 PHEM-ALERT Femtek,Llc. 2003-09-30 Traditional PDF ↗
K012230 PHEM-ALERT Femtek,Llc. 2001-10-09 Traditional PDF ↗
K960648 PHEM-CHEK Femtek, Inc. 1996-05-13 Traditional PDF ↗
K850858 OB-PH - PH TEST PAPER Uro Pharmaceuticals, Inc. 1985-05-24 Traditional PDF ↗

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