510(k) K073634
K073634 is an FDA 510(k) premarket notification submitted by SENTINEL CH. SpA for the device "MULTIGENT CREATININE (ENZYMATIC) ASSAY". The FDA issued a decision of Substantially Equivalent on June 19, 2008. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. SENTINEL CH. SpA has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2008
- Date Received
- December 26, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzymatic Method, Creatinine
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type