Teco Creatinine Enzymatic Reagent Kit
K-Number: K161527 · 2017-07-21
ApplicantTeco Diagnostics, Inc.
Decision Date2017-07-21
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Teco Creatinine Enzymatic Reagent Kit is a medical device manufactured by Teco Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-07-21 under approval number K161527. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Teco Creatinine Enzymatic Reagent Kit?
Teco Creatinine Enzymatic Reagent Kit is a medical device that received FDA 510(k) clearance on 2017-07-21. It is manufactured by Teco Diagnostics, Inc.. The 510(k) number is K161527.
When was Teco Creatinine Enzymatic Reagent Kit approved by the FDA?
Teco Creatinine Enzymatic Reagent Kit received FDA 510(k) clearance on 2017-07-21, under approval number K161527.
What company makes Teco Creatinine Enzymatic Reagent Kit?
Teco Creatinine Enzymatic Reagent Kit is manufactured by Teco Diagnostics, Inc..
What is the FDA product code for Teco Creatinine Enzymatic Reagent Kit?
The FDA product code for Teco Creatinine Enzymatic Reagent Kit is JFY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.