KEM · Class I · 21 CFR 864.4010

FDA Product Code KEM: Agent, Clearing

Leading manufacturers include Richard-Allan Medical Ind., Inc., Anatech, Ltd. and Lerner Laboratories, 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 Apr 05, 1988
XYLENE
K881282
Anatech, Ltd.
Pathology · 11d
Cleared Dec 04, 1987
HEMO-SOL
K874461
Chem Pharm, Inc.
Pathology · 36d
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 Oct 22, 1985
XYLENE SUBSTITUTE
K853694
Lerner Laboratories, Inc.
Pathology · 48d
Cleared Oct 22, 1985
XYLENE SUBSTITUTE MONTANT
K854083
Lerner Laboratories, Inc.
Pathology · 15d
Cleared Aug 21, 1984
PRO-PAR CLEARANT
K842861
Anatech, Ltd.
Pathology · 29d
Cleared Aug 03, 1984
LIMONENE
K842721
E K Ind., Inc.
Pathology · 21d
Cleared Aug 12, 1983
AMERI CLEAR
K832011
Stephens Scientific
Hematology · 50d
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 Nov 05, 1982
HEMO-DE
K822784
Pmp Industries
Pathology · 52d
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