510(k) K955720
K955720 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "AMAX CS-190 COAGULATION ANALYZER SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 13, 1996. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 13, 1996
- Date Received
- Dec 18, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Multipurpose For In Vitro Coagulation Studies
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type
- 510(k)