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FDA Product Code

FDA Product Code DEN — Clearance Directory

Device Class
Class I
Assigned Panel
Immunology
21 CFR Citation
866.5420

510(k) Clearances — 2 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K780325 RID SYSTEM-HUMAN C-REACTIVE PROTEIN Icl Scientific 1978-03-17 Traditional PDF ↗
K771879 GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID Hyland Therapeutic Div., Travenol Laboratories 1977-10-19 Traditional PDF ↗

Product code DEN · Class I · Immunology. Data: openFDA.