510(k) K070824
K070824 is an FDA 510(k) premarket notification submitted by Thermofisher Scientific OY for the device "CREATININE (ENZYMATIC)". The FDA issued a decision of Substantially Equivalent on December 3, 2007. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Thermofisher Scientific OY has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2007
- Date Received
- March 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