510(k) K833352
K833352 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL". The FDA issued a decision of Substantially Equivalent on Nov 3, 1983. The device falls under product code GIL (Plasma, Fibrinogen Control), a Class II device regulated under 21 CFR 864.7340. Warner-Lambert Co. has 49 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 3, 1983
- Date Received
- Sep 28, 1983
- 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