Tina-quant Hemoglobin A1cDx Gen.3
K-Number: K193053 · 2020-03-26
ApplicantRoche Diagnostics Operations (Rdo)
Decision Date2020-03-26
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Tina-quant Hemoglobin A1cDx Gen.3 is a medical device manufactured by Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2020-03-26 under approval number K193053. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tina-quant Hemoglobin A1cDx Gen.3?
Tina-quant Hemoglobin A1cDx Gen.3 is a medical device that received FDA 510(k) clearance on 2020-03-26. It is manufactured by Roche Diagnostics Operations (Rdo). The 510(k) number is K193053.
When was Tina-quant Hemoglobin A1cDx Gen.3 approved by the FDA?
Tina-quant Hemoglobin A1cDx Gen.3 received FDA 510(k) clearance on 2020-03-26, under approval number K193053.
What company makes Tina-quant Hemoglobin A1cDx Gen.3?
Tina-quant Hemoglobin A1cDx Gen.3 is manufactured by Roche Diagnostics Operations (Rdo).
What is the FDA product code for Tina-quant Hemoglobin A1cDx Gen.3?
The FDA product code for Tina-quant Hemoglobin A1cDx Gen.3 is PDJ.
Other Devices by Roche Diagnostics Operations (Rdo)
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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.