FDA product code DLB: Radioimmunoassay, Lsd (125-I)
DLB is the FDA product code for radioimmunoassay, lsd (125-i). It is a Class II device, regulated under 21 CFR 862.3580 and reviewed by the Clinical Toxicology panel. FDA has cleared 7 510(k) submissions under DLB, from 5 different applicants. The average 510(k) review took 61 days (median 59).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Lsd (125-I) |
| Device class | Class II |
| Regulation | 21 CFR 862.3580 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DLB clearance
Top DLB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 3 | 1996-06-21 |
| Behring Diagnostics, Inc. | 1 | 1996-02-23 |
| Microgenics Corp. | 1 | 1996-02-09 |
| Solarcare Technologies Corp,Inc. | 1 | 1995-11-29 |
| Diagnostic Products Corp. | 1 | 1989-05-03 |
Most recent DLB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K961436 | Roche Diagnostic Systems, Inc. | ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) | 1996-06-21 | 67 |
| K955448 | Behring Diagnostics, Inc. | EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS | 1996-02-23 | 86 |
| K955814 | Microgenics Corp. | CEDIA DAU LSD ASSAY | 1996-02-09 | 45 |
| K954073 | Solarcare Technologies Corp,Inc. | STC DIAGNOSTICS LSD MICRO-PLATE EIA | 1995-11-29 | 91 |
| K891167 | Diagnostic Products Corp. | COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT | 1989-05-03 | 58 |
Recalls for DLB devices
openFDA lists no recalls for product code DLB.
Frequently asked questions
What is FDA product code DLB?
DLB is the FDA product code for radioimmunoassay, lsd (125-i). It is a Class II device, regulated under 21 CFR 862.3580 and reviewed by the Clinical Toxicology panel.
What device class is DLB?
Class II, regulation 21 CFR 862.3580. Typical premarket route: 510(k).
How long does a 510(k) take for product code DLB?
Across 7 cleared submissions the average was 61 days from receipt to decision (median 59).
Which companies have the most DLB clearances?
Roche Diagnostic Systems, Inc. (3); Behring Diagnostics, Inc. (1); Microgenics Corp. (1); Solarcare Technologies Corp,Inc. (1); Diagnostic Products Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DLB
- Run a recall and safety report across every DLB manufacturer
- Watch product code DLB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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