K000566 is an FDA 510(k) clearance for the MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS. 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 9, 2000, 16 days after receiving the submission on February 22, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K000566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2000 |
| Decision Date | March 09, 2000 |
| Days to Decision | 16 days |
| Submission Type | Special |
| 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 |