510(k) K161527
K161527 is an FDA 510(k) premarket notification submitted by Teco Diagnostics, Inc. for the device "Teco Creatinine Enzymatic Reagent Kit". The FDA issued a decision of Substantially Equivalent on July 21, 2017. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Teco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2017
- Date Received
- June 2, 2016
- 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