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

Radioimmunoassay, Lsd (125-I)

21 CFR 862.3580 / Clinical Toxicology
FDA source (opens on fda.gov)

DLB is the FDA product code for Radioimmunoassay, Lsd (125-I), a class II device type, regulated under 21 CFR 862.3580. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DLB
Device name
Radioimmunoassay, Lsd (125-I)
Regulation
21 CFR 862.3580
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
7
Ingested recalls
0

Clearances, product code DLB

By decision year
7 clearances under product code DLB with a decision year between 1986 and 1996, 1996 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DLB by decision year
YearClearances
19861
19871
19891
19951
19963

Applicants with the most clearances

Product code DLB
Applicants holding the most 510(k) clearances under product code DLB
ApplicantClearances
Roche Diagnostic Systems, Inc.3
Behring Diagnostics, Inc.1
Siemens Healthcare Diagnostics Inc.1
Microgenics Corporation1
Solarcare Technologies Corp,Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code