510(k) K880674
K880674 is an FDA 510(k) premarket notification submitted by Icn Micromedic Systems for the device "MICROMEDIC CRACKPOT RIA KIT". The FDA issued a decision of Substantially Equivalent on October 6, 1988. The device falls under product code KLN (Radioimmunoassay, Cocaine Metabolite), a Class II device regulated under 21 CFR 862.3250. Icn Micromedic Systems has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 1988
- Date Received
- February 19, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Cocaine Metabolite
- Device Class
- Class II
- Regulation Number
- 862.3250
- Review Panel
- TX
- Submission Type