510(k) K850592
K850592 is an FDA 510(k) premarket notification submitted by Chrono-Log Corp. for the device "PLATELET AGGREGATION REAGENT". The FDA issued a decision of Substantially Equivalent on May 13, 1985. The device falls under product code JBX (Aggregrometer, Platelet), a Class II device regulated under 21 CFR 864.6675. Chrono-Log Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 1985
- Date Received
- February 15, 1985
- 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