510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DJDClass II

Enzyme Immunoassay, Primidone

21 CFR 862.3680 / Clinical Toxicology
FDA source (opens on fda.gov)

DJD is the FDA product code for Enzyme Immunoassay, Primidone, a class II device type, regulated under 21 CFR 862.3680. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DJD
Device name
Enzyme Immunoassay, Primidone
Regulation
21 CFR 862.3680
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
8
Ingested recalls
0

Clearances, product code DJD

By decision year
8 clearances under product code DJD with a decision year between 1979 and 1997, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DJD by decision year
YearClearances
19791
19801
19822
19831
19841
19911
19971

Applicants with the most clearances

Product code DJD
Applicants holding the most 510(k) clearances under product code DJD
ApplicantClearances
Syva Co.2
Abbott Medical1
Beckman Instruments, Inc.1
E.I. Dupont de Nemours & Co., Inc.1
Miles Laboratories, Inc.1
Schiapparelli Biosystems, Inc.1
Syva Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code