510(k) K950221
K950221 is an FDA 510(k) premarket notification submitted by Izon Business Products, Inc. for the device "MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)". The FDA issued a decision of Substantially Equivalent (kit, denovo) on March 21, 1995. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660. Izon Business Products, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- March 21, 1995
- Date Received
- January 19, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Screening, Urine
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type