510(k) K972260
K972260 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "CS-400 COAGULATION ANALYZER SYSTEM (A1208)". The FDA issued a decision of Substantially Equivalent on Oct 20, 1997. 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
- Oct 20, 1997
- Date Received
- Jun 17, 1997
- 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)