KDX · Class I · 21 CFR 864.4010

FDA Product Code KDX: Solution, Decalcifier, Acid Containing

Leading manufacturers include Surgipath, Richard-Allan Medical Ind., Inc. and Lerner Laboratories, Inc..

8
Total
8
Cleared
26d
Avg days
1981
Since

FDA 510(k) Cleared Solution, Decalcifier, Acid Containing Devices (Product Code KDX)

8 devices
1–8 of 8
Cleared Aug 06, 1987
DECALCIFYING SOLUTION
K872625
Stephens Scientific
Pathology · 31d
Cleared Mar 20, 1985
SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E
K850636
Fisher Scientific Co., LLC
Pathology · 29d
Cleared Aug 03, 1984
DECALCIFIER SOLUTION
K842726
E K Ind., Inc.
Pathology · 21d
Cleared May 02, 1984
DECALCIFIER I
K841488
Surgipath Medical Industries, Inc.
Pathology · 22d
Cleared Aug 03, 1982
VOLU-SOL DECALCIFER
K822036
Volu Sol Medical Industries
Pathology · 22d
Cleared Jun 02, 1982
FORMICAL
K821443
Lerner Laboratories, Inc.
Chemistry · 19d
Cleared Jul 28, 1981
CAL-RITE
K811801
Richard-Allan Medical Ind., Inc.
Hematology · 34d
Cleared Apr 23, 1981
DECALCIFIER II
K810836
Surgipath
Pathology · 28d

About Product Code KDX - Regulatory Context