510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DIEClass I

Heavy Metals Control Materials

21 CFR 862.3280 / Clinical Toxicology
FDA source (opens on fda.gov)

DIE is the FDA product code for Heavy Metals Control Materials, a class I device type, regulated under 21 CFR 862.3280. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DIE
Device name
Heavy Metals Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code DIE

By decision year
5 clearances under product code DIE with a decision year between 1986 and 2002, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DIE by decision year
YearClearances
19861
19892
19991
20021

Applicants with the most clearances

Product code DIE
Applicants holding the most 510(k) clearances under product code DIE
ApplicantClearances
Bio-Rad3
Actio, Inc.1
Shape Products Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code