VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
FDA 510(k) clearance K142595 · decided 2015-06-04
Clearance details
- K-number
- K142595
- Device name
- VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
- Applicant
- Ortho Clinical Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2014-09-15
- Decision date
- 2015-06-04
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- PDJ
- Device class
- 2
- Regulation number
- 862.1373
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of per recall (Z-1628-2023) | Ortho-Clinical Diagnostics, Inc. | 2023-05-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S017) | Ortho-Clinical Diagnostics | 2023-01-24 |
| VITROS Anti-HBe (P100001/S016) | Ortho-Clinical Diagnostics | 2019-06-19 |
| VITROS Anti-HBc (P030024/S029) | Ortho-Clinical Diagnostics | 2019-06-19 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S028) | Ortho-Clinical Diagnostics | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S015) | Ortho-Clinical Diagnostics | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S027) | Ortho-Clinical Diagnostics | 2018-10-16 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S025) | Ortho-Clinical Diagnostics | 2018-07-02 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S026) | Ortho-Clinical Diagnostics | 2018-07-02 |