510(k) K962596
K962596 is an FDA 510(k) premarket notification submitted by Customed, Inc. for the device "CUSTOMED BLOOD EXTRACTION KIT". The FDA issued a decision of Substantially Equivalent on September 27, 1996. The device falls under product code GJE (Tray, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Customed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1996
- Date Received
- July 2, 1996
- 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