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

Cholinesterase Test Paper

21 CFR 862.3240 / Clinical Toxicology
FDA source (opens on fda.gov)

DIG is the FDA product code for Cholinesterase Test Paper, a class I device type, regulated under 21 CFR 862.3240. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DIG
Device name
Cholinesterase Test Paper
Regulation
21 CFR 862.3240
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
1
Ingested recalls
0

Clearances, product code DIG

By decision year
1 clearance under product code DIG with a decision year between 2003 and 2003, 2003 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DIG by decision year
YearClearances
20031

Applicants with the most clearances

Product code DIG
Applicants holding the most 510(k) clearances under product code DIG
ApplicantClearances
Cozart Bioscience, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code