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
DIJClass II

Lead, Delta Amino Levulinic Acid

21 CFR 862.3550 / Clinical Toxicology
FDA source (opens on fda.gov)

DIJ is the FDA product code for Lead, Delta Amino Levulinic Acid, a class II device type, regulated under 21 CFR 862.3550. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DIJ
Device name
Lead, Delta Amino Levulinic Acid
Regulation
21 CFR 862.3550
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
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code DIJ

By decision year
2 clearances under product code DIJ with a decision year between 1980 and 2003, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DIJ by decision year
YearClearances
19801
20031

Applicants with the most clearances

Product code DIJ
Applicants holding the most 510(k) clearances under product code DIJ
ApplicantClearances
Quantimetrix Corp.1
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code

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