510(k) K083809
K083809 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "CREATININE". The FDA issued a decision of Substantially Equivalent on April 7, 2009. The device falls under product code CGX (Alkaline Picrate, Colorimetry, Creatinine), a Class II device regulated under 21 CFR 862.1225. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 2009
- Date Received
- December 22, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alkaline Picrate, Colorimetry, Creatinine
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type