Tina-quant Transferrin ver.2 (urine application)
FDA 510(k) K182095 · Roche Diagnostics Operations (Rdo)
510(k) numberK182095
Submission
- Device name
- Tina-quant Transferrin ver.2 (urine application)
- Applicant
- Roche Diagnostics Operations (Rdo)
Indianapolis, IN, US - Received
- August 3, 2018
- Decision date
- November 5, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DDG – Transferrin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5880
- Specialty
- Immunology
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| K063663 | Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…DDG · Traditional | Dade Behring, Inc. | 03/21/2007SE |
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| K053075 | N Antisera to Human TransferrinDDG · Traditional | Dade Behring, Inc. | 03/16/2006SE |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3PDJ · Traditional | 03/26/2020SE |
| K192072 | Tina-quant C-Reactive Protein IVDCN · Traditional | 02/21/2020SE |
| K183517 | Ammonia IIJIF · Traditional | 02/08/2019SE |
| K171080 | ALP IFCC Gen.2CJE · Special | 05/10/2017SE |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayPDJ · Traditional | 12/19/2016SE |
| K162593 | HDL-Cholesterol Gen.4LBS · Traditional | 10/19/2016SE |
| K161817 | Tina-quant Cystatin C Gen.2NDY · Special | 07/27/2016SE |
| K160570 | Creatine KinaseJHS · Traditional | 05/25/2016SE |
| K152245 | ONLINE TDM Vancomycin Gen.3LEH · Traditional | 01/08/2016SE |
| K151578 | Carbamazepine Gen 4KLT · Traditional | 10/22/2015SE |
Questions and answers
When was Tina-quant Transferrin ver.2 (urine application) cleared by the FDA?
Tina-quant Transferrin ver.2 (urine application) (K182095) received a 510(k) decision of Substantially Equivalent on November 5, 2018, 94 days after the submission was received.
What is the product code of K182095?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.