Tina-quant C-Reactive Protein IV
K-Number: K192072 · 2020-02-21
ApplicantRoche Diagnostics Operations (Rdo)
Decision Date2020-02-21
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Tina-quant C-Reactive Protein IV is a medical device manufactured by Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2020-02-21 under approval number K192072. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tina-quant C-Reactive Protein IV?
Tina-quant C-Reactive Protein IV is a medical device that received FDA 510(k) clearance on 2020-02-21. It is manufactured by Roche Diagnostics Operations (Rdo). The 510(k) number is K192072.
When was Tina-quant C-Reactive Protein IV approved by the FDA?
Tina-quant C-Reactive Protein IV received FDA 510(k) clearance on 2020-02-21, under approval number K192072.
What company makes Tina-quant C-Reactive Protein IV?
Tina-quant C-Reactive Protein IV is manufactured by Roche Diagnostics Operations (Rdo).
What is the FDA product code for Tina-quant C-Reactive Protein IV?
The FDA product code for Tina-quant C-Reactive Protein IV is DCN.
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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.