Product code DLB— Clinical Toxicology
ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)
- Classification name
- Radioimmunoassay, Lsd (125-I)
- Device class
- Class 2
- Regulation
- 21 CFR 862.3580
- Advisory panel
- Clinical Toxicology
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code DLB
FDA has cleared devices under product code DLB between 1986 and 1996, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1996
- 1995
- 1989
- 1987
- 1986
Top applicants under product code DLB
Recent clearances under product code DLB
- K961436 — ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)
- K955448 — EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS
- K955814 — CEDIA DAU LSD ASSAY
- K954073 — STC DIAGNOSTICS LSD MICRO-PLATE EIA
- K891167 — COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT
- K874270 — REVISED LABELING FOR LSD TEST KIT
- K860525 — ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD
Data sourced from openFDA. This site is unofficial and independent of the FDA.