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FDA Product Code

FDA Product Code LEA — Clearance Directory

Device Class
Class I
Assigned Panel
Pathology
21 CFR Citation
864.4010

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K873594 TIF FECAL TEST Devetec, Inc. 1987-09-29 Traditional PDF ↗
K770592 CYTOLOGY FIXATIVE Surgipath Medical Industries, Inc. 1977-05-20 Traditional PDF ↗
K761000 PAP-TRAY I (CATALOG #C600-1) Lerner Laboratories, Inc. 1976-12-06 Traditional PDF ↗
K761001 PAP-TRAY II (CATALOG #C600-2) Lerner Laboratories, Inc. 1976-12-06 Traditional PDF ↗

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