510(k) K060083
K060083 is an FDA 510(k) premarket notification submitted by Streck for the device "NRBC-CHEX FOR LH". The FDA issued a decision of Substantially Equivalent on February 9, 2006. 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 9, 2006
- Date Received
- January 11, 2006
- 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