510(k) K934741
K934741 is an FDA 510(k) premarket notification submitted by Clinical Controls, Inc. for the device "LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2". The FDA issued a decision of Substantially Equivalent on Sep 8, 1994. The device falls under product code GIL (Plasma, Fibrinogen Control), a Class II device regulated under 21 CFR 864.7340. Clinical Controls, Inc. has 17 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 8, 1994
- Date Received
- Oct 1, 1993
- 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
- 510(k) Exempt