510(k) K080016
K080016 is an FDA 510(k) premarket notification submitted by Streck for the device "NRBC-CHEX FOR ADVIA". The FDA issued a decision of Substantially Equivalent on February 5, 2008. The device falls under product code GJR (Control, Red-Cell), a Class II device regulated under 21 CFR 864.8625. Streck has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 2008
- Date Received
- January 3, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, Red-Cell
- Device Class
- Class II
- Regulation Number
- 864.8625
- Review Panel
- HE
- Submission Type