VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RAN — Ortho-Clinical Diagnostics, Inc. (510
VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RAN — Ortho-Clinical Diagnostics, Inc. (510 is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RAN; Applican
| Device name | VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RAN |
|---|---|
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Clearance track | 510(k) |
| Submission number | K990783 |
| Decision | Substantially Equivalent |
| Decision date | 1999-03-25 |
| Date received | 1999-03-09 |
| Product code | JJX |
| Device class | 1 |
| Medical specialty | Clinical Chemistry |
| Applicant location | NY, US |
| Source | openFDA device |
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