510(k) K770395
K770395 is an FDA 510(k) premarket notification submitted by Bay Area Hema. Onco. Clinic. & Res. L for the device "THROMBO-CETIN (RISTOCETIN)". The FDA issued a decision of Substantially Equivalent on March 21, 1977. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Bay Area Hema. Onco. Clinic. & Res. L has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1977
- Date Received
- February 28, 1977
- 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