DIE · Class I · 21 CFR 862.3280

FDA Product Code DIE: Heavy Metals Control Materials

Leading manufacturers include Bio-Rad.

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

Chemistry · 56d

Cleared Apr 16, 1999

LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405

Toxicology · 28d

Cleared Dec 19, 1989

LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II

Toxicology · 272d

About Product Code DIE - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Apr 22, 2002

Product Code Info

Code	DIE
Device class	Class I
CFR	21 CFR 862.3280
Panel	Toxicology

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