VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
FDA 510(k) clearance K101921 · decided 2010-10-22
Clearance details
- K-number
- K101921
- Device name
- VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
- Applicant
- Ortho-Clinical Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2010-07-09
- Decision date
- 2010-10-22
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- CEW
- Device class
- 2
- Regulation number
- 862.1545
- 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 Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measure recall (Z-0878-2023) | Ortho-Clinical Diagnostics, Inc. | 2023-01-04 |
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 |