FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
K Number: K160571
·
Decision Dec 19, 2016
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
25
Applicant Total
14
Review Days
294
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Basic Information
- Device Name
- cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
- K Number
- K160571
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1373
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Operations (Rdo)
- Date Received
- February 29, 2016
- Decision Date
- December 19, 2016
- Product Code
- PDJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PDJ | Hemoglobin A1c Test System | FDA class 2 | Clinical Chemistry |
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Other Clearances by Roche Diagnostics Operations (Rdo)
| K Number | Device Name | ||
|---|---|---|---|
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | Mar 26, 2020 | Substantially Equivalent |
| K192072 | Tina-quant C-Reactive Protein IV | Feb 21, 2020 | Substantially Equivalent |
| K183517 | Ammonia II | Feb 8, 2019 | Substantially Equivalent |
| K182095 | Tina-quant Transferrin ver.2 (urine application) | Nov 5, 2018 | Substantially Equivalent |
| K171080 | ALP IFCC Gen.2 | May 10, 2017 | Substantially Equivalent |
| K162593 | HDL-Cholesterol Gen.4 | Oct 19, 2016 | Substantially Equivalent |
| K161817 | Tina-quant Cystatin C Gen.2 | Jul 27, 2016 | Substantially Equivalent |
| K160570 | Creatine Kinase | May 25, 2016 | Substantially Equivalent |
| K152245 | ONLINE TDM Vancomycin Gen.3 | Jan 8, 2016 | Substantially Equivalent |
| K151578 | Carbamazepine Gen 4 | Oct 22, 2015 | Substantially Equivalent |