510(k) K925468
K925468 is an FDA 510(k) premarket notification submitted by J.J. Skinner, Inc. for the device "JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on April 11, 1994. The device falls under product code GJE (Tray, Blood Collection), a Class II device regulated under 21 CFR 862.1675. J.J. Skinner, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- April 11, 1994
- Date Received
- October 29, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Blood Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type