510(k) K935054
K935054 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "FACTOR X DEFICIENT PLASMA". The FDA issued a decision of Substantially Equivalent on Mar 7, 1994. The device falls under product code GJT (Plasma, Coagulation Factor Deficient), a Class II device regulated under 21 CFR 864.7290. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 7, 1994
- Date Received
- Oct 21, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Plasma, Coagulation Factor Deficient
- Device Class
- Class II
- Regulation Number
- 864.7290
- Review Panel
- HE
- Submission Type
- 510(k)