510(k) K964139
K964139 is an FDA 510(k) premarket notification submitted by Dade Intl., Inc. for the device "SYSMEX CA-6000". The FDA issued a decision of Substantially Equivalent on February 6, 1997. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. Dade Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 1997
- Date Received
- October 15, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Coagulation, Automated
- Device Class
- Class II
- Regulation Number
- 864.5400
- Review Panel
- HE
- Submission Type