Product code KLN— Clinical Toxicology
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE
- Classification name
- Radioimmunoassay, Cocaine Metabolite
- Device class
- Class 2
- Regulation
- 21 CFR 862.3250
- Advisory panel
- Clinical Toxicology
- Total cleared
- 14
- First cleared
- Most recent
Market context for product code KLN
FDA has cleared devices under product code KLN between 1983 and 2001, filed by 7 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
- 2001
- 1991
- 1990
- 1988
- 1987
- 1986
- 1983
Top applicants under product code KLN
Recent clearances under product code KLN
- K010868 — PSYCHEMEDICS RIA COCAINE ASSAY
- K913867 — URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)
- K913722 — ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
- K912756 — ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE
- K910122 — TARGET COCAINE METABOLITE-R
- K910123 — TARGET COCAINE METABOLITE-V
- K910044 — MILENIA COCAINE METABOLITE
- K905730 — ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)
- K904995 — ABUSCREEN ONLINE TM FOR COCAINE METABOLITE
- K880674 — MICROMEDIC CRACKPOT RIA KIT
- K871549 — RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]
- K870740 — COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5
- K862218 — DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT
- K830480 — ABUSCREEN RADIOIMMUNOASSAY-COCAINE META
Data sourced from openFDA. This site is unofficial and independent of the FDA.