VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK
FDA 510(k) clearance K983875 · decided 1999-05-14
Clearance details
- K-number
- K983875
- Device name
- VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-02
- Decision date
- 1999-05-14
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- LTK
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ortho-Clinical Diagnostics
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagn recall (Z-0525-2014) | Ortho-Clinical Diagnostics | 2013-12-17 |
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 |