VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS
FDA 510(k) clearance K042476 · decided 2004-12-01
Clearance details
- K-number
- K042476
- Device name
- VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-13
- Decision date
- 2004-12-01
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- LEG
- Device class
- 2
- Regulation number
- 862.3645
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710 --- Ortho- Clinical Diagnosti recall (Z-0984-2012) | Ortho-Clinical Diagnostics | 2012-02-08 |
| VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid r recall (Z-0866-05) | Ortho-Clinical Diagnostics | 2005-06-04 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITROS Anti-HBc IgM (P030026/S037) | Ortho-Clinical Diagnostics, Inc. | 2023-01-24 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018) | Ortho-Clinical Diagnostics, Inc. | 2023-01-24 |
| VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036) | Ortho-Clinical Diagnostics, Inc. | 2020-10-22 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033) | Ortho-Clinical Diagnostics, Inc. | 2020-08-07 |
| VITROS Anti-HBs (P000014/S035) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS Anti-HBc IgM (P030026/S036) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS HBeAg (P090028/S017) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |