510(k) K946265
K946265 is an FDA 510(k) premarket notification submitted by Clinical Controls, Inc. for the device "FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3". The FDA issued a decision of Substantially Equivalent on August 24, 1995. The device falls under product code GIL (Plasma, Fibrinogen Control), a Class II device regulated under 21 CFR 864.7340. Clinical Controls, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1995
- Date Received
- December 23, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plasma, Fibrinogen Control
- Device Class
- Class II
- Regulation Number
- 864.7340
- Review Panel
- HE
- Submission Type