DIE · Class I · 21 CFR 862.3280

FDA Product Code DIE: Heavy Metals Control Materials

Leading manufacturers include Bio-Rad, Shape Products Co. and Actio, Inc..

5
Total
5
Cleared
92d
Avg days
1986
Since

FDA 510(k) Cleared Heavy Metals Control Materials Devices (Product Code DIE)

5 devices
1–5 of 5
Cleared Apr 22, 2002
LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
K020610
Bio-Rad
Chemistry · 56d
Cleared Apr 16, 1999
LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405
K990928
Bio-Rad
Toxicology · 28d
Cleared Dec 19, 1989
LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II
K891691
Bio-Rad
Toxicology · 272d
Cleared Apr 10, 1989
SHAPE-ACTIO METAL TOXICOLOGY CONTROL
K890721
Actio, Inc.
Toxicology · 56d
Cleared Nov 24, 1986
SHAPE-ACTIO METAL TOXICOLOGY CONTROL
K863915
Shape Products Co.
Toxicology · 47d

About Product Code DIE - Regulatory Context