LEA · Class I · 21 CFR 864.4010

FDA Product Code LEA: Preservative, Cytological

Leading manufacturers include Surgipath Medical Industries, Inc..

4
Total
4
Cleared
34d
Avg days
1976
Since

FDA 510(k) Cleared Preservative, Cytological Devices (Product Code LEA)

4 devices
1–4 of 4
Cleared May 20, 1977
CYTOLOGY FIXATIVE
K770592
Surgipath Medical Industries, Inc.
Pathology · 53d

About Product Code LEA - Regulatory Context