meddevicedb.com FDA Device Reference

FDA Product Code

FDA Product Code LIJ — Clearance Directory

Device Class
Class I
Assigned Panel
Pathology
21 CFR Citation
864.4400

510(k) Clearances — 2 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K855034 AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT Bartels Immunodiagnostic Supplies, Inc. 1986-03-11 Traditional PDF ↗
K820336 DAKO PAP KIT K509 Dako Corp. 1982-07-13 Traditional PDF ↗

Product code LIJ · Class I · Pathology. Data: openFDA.