510(k) K021941
K021941 is an FDA 510(k) premarket notification submitted by Itl Corporation Pty, Ltd. for the device "SAMPLOK LUER KIT". The FDA issued a decision of Substantially Equivalent on July 2, 2002. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Itl Corporation Pty, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2002
- Date Received
- June 13, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type