The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros Immunodiagnostic Products Ck-mb Reagent Pack ; Vitros Immunodiagnostic Products Ck-mb Calibrators.
| Device ID | K993068 |
| 510k Number | K993068 |
| Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Marlene Shulman |
| Correspondent | Marlene Shulman ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-13 |
| Decision Date | 1999-10-04 |
| Summary: | summary |