meddevicedb.com FDA Device Reference

FDA Product Code

FDA Product Code JZH — Clearance Directory

Device Class
Class II
Assigned Panel
Immunology
21 CFR Citation
866.5320

510(k) Clearances — 6 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K964843 IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT Beckman Instruments, Inc. 1997-03-06 Traditional PDF ↗
K882623 PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM Technicon Instruments Corp. 1988-07-08 Traditional PDF ↗
K831959 RADIAL IMMUNO-TEST FOR HUMAN FACTOR B Kent Laboratories, Inc. 1983-07-19 Traditional PDF ↗
K811740 KALLESTAD'S ENDOPLATE FACTOR B TEST Kallestad Laboratories, Inc. 1981-07-16 Traditional PDF ↗
K781016 C3PA (GBG) PROPERDIN FACTOR B Icl Scientific 1978-08-14 Traditional PDF ↗
K772084 LAS-R HUMAN C3 PROACTIVATOR TEST Hyland Therapeutic Div., Travenol Laboratories 1978-01-24 Traditional PDF ↗

Product code JZH · Class II · Immunology. Data: openFDA.