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FDA Product Code

FDA Product Code OWK — Clearance Directory

Device Class
Class II
Assigned Panel
Immunology
21 CFR Citation
866.6040

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
K091960 VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 Abbott Molecular, Inc. 2011-08-29 Traditional PDF ↗

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