VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)
FDA 510(k) clearance K072440 · decided 2007-09-20
Clearance details
- K-number
- K072440
- Device name
- VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-30
- Decision date
- 2007-09-20
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- CJY
- Device class
- 2
- Regulation number
- 862.1145
- 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 Ca Slides; Catalog Number: 145 0261; recall (Z-2335-2025) | Ortho-Clinical Diagnostics, Inc. | 2025-08-15 |
| ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT. recall (Z-1831-2025) | Mckesson Medical-Surgical Inc. Corporate Office | 2025-05-27 |
| VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VIT recall (Z-0302-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |
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 |