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FDA Product Code

FDA Product Code LFP — Clearance Directory

Device Class
Class II
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.1770

510(k) Clearances — 6 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K990039 GAMBRO DQM 200 Gambro Healthcare 2000-01-27 Traditional PDF ↗
K992847 HICHEM BUN REAGENT Elan Holdings, Inc. 1999-10-14 Traditional PDF ↗
K963537 SIGMA DIAGNOSTICS BUN REAGENT Sigma Diagnostics, Inc. 1996-10-24 Traditional PDF ↗
K933679 SIGMA BUN REAGENT Sigma Chemical Co. 1993-12-17 Traditional PDF ↗
K873132 BUN REAGENT KIT A-Kem, Inc. 1987-10-23 Traditional PDF ↗
K812945 LIQUILYME BUN REAGENT Amresco, Inc. 1981-11-06 Traditional PDF ↗

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