DLB
7 FDA 510(k) clearances · Product code
59 daysmedian time to decision
91 days90th percentile
7clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Lsd (125-I)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3580
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) (K961436) | Roche Diagnostic Systems, Inc. | 1996-06-21 |
| EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS (K955448) | Behring Diagnostics, Inc. | 1996-02-23 |
| CEDIA DAU LSD ASSAY (K955814) | Microgenics Corp. | 1996-02-09 |
| STC DIAGNOSTICS LSD MICRO-PLATE EIA (K954073) | Solarcare Technologies Corp,Inc. | 1995-11-29 |
| COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT (K891167) | Diagnostic Products Corp. | 1989-05-03 |
| REVISED LABELING FOR LSD TEST KIT (K874270) | Roche Diagnostic Systems, Inc. | 1987-11-13 |
| ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD (K860525) | Roche Diagnostic Systems, Inc. | 1986-04-11 |
Track DLB automatically
Every clearance here is in the API, with alerts when new ones post.