The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostic Products Troponin I Reagent Pack And Calibrators.
| Device ID | K031031 |
| 510k Number | K031031 |
| Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Ann M Quinn |
| Correspondent | Ann M Quinn Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-01 |
| Decision Date | 2003-09-29 |
| Summary: | summary |