K984289 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK. This device is classified as a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II - Special Controls, product code LTJ).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on March 12, 1999, 101 days after receiving the submission on December 1, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K984289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1998 |
| Decision Date | March 12, 1999 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LTJ — Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |