510(k) K954437
K954437 is an FDA 510(k) premarket notification submitted by Haemoscope Corp. for the device "THROMBELASTOGRAPH COAGULATION ANALYZER 3000S". The FDA issued a decision of Substantially Equivalent on January 30, 1996. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. Haemoscope Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1996
- Date Received
- September 22, 1995
- 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