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

Gas Chromatography, Ethosuximide

21 CFR 862.3380 / Clinical Toxicology
FDA source (opens on fda.gov)

DIY is the FDA product code for Gas Chromatography, Ethosuximide, a class II device type, regulated under 21 CFR 862.3380. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DIY
Device name
Gas Chromatography, Ethosuximide
Regulation
21 CFR 862.3380
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code DIY

By decision year
1 clearance under product code DIY with a decision year between 1978 and 1978, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DIY by decision year
YearClearances
19781

Applicants with the most clearances

Product code DIY
Applicants holding the most 510(k) clearances under product code DIY
ApplicantClearances
Vitek Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DIY.