KEM · Class I · 21 CFR 864.4010

FDA Product Code KEM: Agent, Clearing

Leading manufacturers include E K Ind., Inc. and Helena Laboratories.

15
Total
15
Cleared
27d
Avg days
1981
Since

FDA 510(k) Cleared Agent, Clearing Devices (Product Code KEM)

15 devices
1–15 of 15
Cleared May 06, 1986
PERMACLEAR SOLUTION CAT. NO. 4950
K861490
Helena Laboratories
Pathology · 14d
Cleared Aug 03, 1984
LIMONENE
K842721
E K Ind., Inc.
Pathology · 21d

About Product Code KEM - Regulatory Context