510(k) K990398
K990398 is an FDA 510(k) premarket notification submitted by Array Medical, Inc. for the device "PLATELETWORKS". The FDA issued a decision of Substantially Equivalent on December 1, 1999. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Array Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 1999
- Date Received
- February 9, 1999
- 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