510(k) K971858
K971858 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)". The FDA issued a decision of Substantially Equivalent on Oct 9, 1997. The device falls under product code KQJ (System, Fibrinogen Determination), a Class II device regulated under 21 CFR 864.7340. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 9, 1997
- Date Received
- May 20, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Fibrinogen Determination
- Device Class
- Class II
- Regulation Number
- 864.7340
- Review Panel
- HE
- Submission Type
- 510(k)