510(k) K994341
K994341 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "FIBRINOGEN CALIBRATOR KIT". The FDA issued a decision of Substantially Equivalent on March 3, 2000. The device falls under product code GFX (Fibrinogen Standard), a Class II device regulated under 21 CFR 864.7340. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 3, 2000
- Date Received
- December 23, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fibrinogen Standard
- Device Class
- Class II
- Regulation Number
- 864.7340
- Review Panel
- HE
- Submission Type