510(k) K965113
K965113 is an FDA 510(k) premarket notification submitted by Crestat Diagnostics, Inc. for the device "N-ASSAY TIA FIBRINOGEN TEST KIT". The FDA issued a decision of Substantially Equivalent on Apr 16, 1997. The device falls under product code KQJ (System, Fibrinogen Determination), a Class II device regulated under 21 CFR 864.7340. Crestat Diagnostics, Inc. has 28 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 16, 1997
- Date Received
- Dec 20, 1996
- 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)