510(k) K962426
K962426 is an FDA 510(k) premarket notification submitted by Chrono-Log Corp. for the device "CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592". The FDA issued a decision of Substantially Equivalent on Oct 22, 1996. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Chrono-Log Corp. has 15 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 22, 1996
- Date Received
- Jun 24, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Automated Platelet Aggregation
- Device Class
- Class II
- Regulation Number
- 864.5700
- Review Panel
- HE
- Submission Type
- 510(k)