510(k) K073367
K073367 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL FIBRINOGEN-C". The FDA issued a decision of Substantially Equivalent on Dec 27, 2007. The device falls under product code KQJ (System, Fibrinogen Determination), a Class II device regulated under 21 CFR 864.7340. Instrumentation Laboratory CO has 326 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 27, 2007
- Date Received
- Nov 30, 2007
- Clearance Type
- Special
- 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)