510(k) K193053
K193053 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations (Rdo) for the device "Tina-quant Hemoglobin A1cDx Gen.3". The FDA issued a decision of Substantially Equivalent on March 26, 2020. The device falls under product code PDJ (Hemoglobin A1c Test System), a Class II device regulated under 21 CFR 862.1373. Roche Diagnostics Operations (Rdo) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2020
- Date Received
- November 1, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemoglobin A1c Test System
- Device Class
- Class II
- Regulation Number
- 862.1373
- Review Panel
- CH
- Submission Type
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.