510(k) K981206
K981206 is an FDA 510(k) premarket notification submitted by Cardiovascular Diagnostics, Inc. for the device "TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)". The FDA issued a decision of Substantially Equivalent on May 26, 1998. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. Cardiovascular Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1998
- Date Received
- April 1, 1998
- 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