510(k) K981248
K981248 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "SIGMA DIAGNOSTICS ACCUCLOT CONTROL I". The FDA issued a decision of Substantially Equivalent on Apr 29, 1998. The device falls under product code GGN (Plasma, Coagulation Control), 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
- Apr 29, 1998
- Date Received
- Apr 6, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Plasma, Coagulation Control
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type
- 510(k) Exempt