510(k) K760159
K760159 is an FDA 510(k) premarket notification submitted by Chrono-Log Corp. for the device "AGGREGOMETER, DUAL CHANNEL PLATELET". The FDA issued a decision of Substantially Equivalent on Jul 20, 1976. The device falls under product code JBX (Aggregrometer, Platelet), a Class II device regulated under 21 CFR 864.6675. Chrono-Log Corp. has 15 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 20, 1976
- Date Received
- Jul 2, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Aggregrometer, Platelet
- Device Class
- Class II
- Regulation Number
- 864.6675
- Review Panel
- HE
- Submission Type
- 510(k)