DLB — Radioimmunoassay, Lsd (125-I) Class II
FDA product code DLB covers "Radioimmunoassay, Lsd (125-I)", a Class II medical device regulated under 21 CFR 862.3580. Submissions are reviewed by the Clinical Toxicology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DLB
- Device Class
- Class II
- Regulation Number
- 862.3580
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K961436 | roche diagnostic systems | ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) | June 21, 1996 |
| K955448 | behring diagnostics | EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS | February 23, 1996 |
| K955814 | microgenics | CEDIA DAU LSD ASSAY | February 9, 1996 |
| K954073 | solarcare technologies corp | STC DIAGNOSTICS LSD MICRO-PLATE EIA | November 29, 1995 |
| K891167 | diagnostic products | COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT | May 3, 1989 |
| K874270 | roche diagnostic systems | REVISED LABELING FOR LSD TEST KIT | November 13, 1987 |
| K860525 | roche diagnostic systems | ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD | April 11, 1986 |