LEA · Class I · 21 CFR 864.4010

FDA Product Code LEA: Preservative, Cytological

Leading manufacturers include Lerner Laboratories, Inc., Surgipath Medical Industries, Inc. and Devetec, 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 Sep 29, 1987
TIF FECAL TEST
K873594
Devetec, Inc.
Pathology · 25d
Cleared May 20, 1977
CYTOLOGY FIXATIVE
K770592
Surgipath Medical Industries, Inc.
Pathology · 53d
Cleared Dec 06, 1976
PAP-TRAY I (CATALOG #C600-1)
K761000
Lerner Laboratories, Inc.
Pathology · 28d
Cleared Dec 06, 1976
PAP-TRAY II (CATALOG #C600-2)
K761001
Lerner Laboratories, Inc.
Pathology · 28d

About Product Code LEA - Regulatory Context