Teco Creatinine Enzymatic Reagent Kit— 510(k) K161527
Substantially EquivalentTeco Diagnostics, Inc.
FDA 510(k) clearance K161527 for Teco Creatinine Enzymatic Reagent Kit, Substantially Equivalent on 2017-07-21. Applicant: Teco Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Teco Diagnostics, Inc.
- Product code
- Code JFY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
Recent devices under product code JFY
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