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DKPClass II

Radioimmunoassay, Phenobarbital

21 CFR 862.3660 / Clinical Toxicology

DKP is the FDA product code for Radioimmunoassay, Phenobarbital, a class II device type, regulated under 21 CFR 862.3660. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DKP
Device name
Radioimmunoassay, Phenobarbital
Regulation
21 CFR 862.3660
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
3
Ingested recalls
0

Clearances, product code DKP

By decision year
3 clearances under product code DKP with a decision year between 1977 and 1984, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DKP by decision year
YearClearances
19771
19801
19841

Applicants with the most clearances

Product code DKP
Applicants holding the most 510(k) clearances under product code DKP
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1
Bio-Rad1
Clinical Assays, 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 DKP.