KEM · Class I · 21 CFR 864.4010

FDA Product Code KEM: Agent, Clearing

Leading manufacturers include Richard-Allan Medical Ind., Inc., E K Ind., Inc. and Surgipath Medical Industries, Inc..

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 Jan 07, 1986
CLEARENE, CLEARING AGENT
K855109
Surgipath Medical Industries, Inc.
Pathology · 15d
Cleared Aug 03, 1984
LIMONENE
K842721
E K Ind., Inc.
Pathology · 21d
Cleared Aug 12, 1983
CLEAR-RITE 3
K832451
Richard-Allan Medical Ind., Inc.
Pathology · 18d
Cleared Mar 24, 1983
CLARIFIER-RICHARD-ALLAN
K830627
Richard-Allan Medical Ind., Inc.
Pathology · 23d
Cleared Oct 29, 1981
CLEAR-RITE II
K812846
Richard-Allan Medical Ind., Inc.
Hematology · 20d
Cleared Oct 29, 1981
XYLENE
K812847
Richard-Allan Medical Ind., Inc.
Hematology · 20d
Cleared Jul 28, 1981
CLEAR-RITE
K811798
Richard-Allan Medical Ind., Inc.
Hematology · 34d

About Product Code KEM - Regulatory Context