The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros Immunodiagnostic Products Cortisol Reagent Pack And Calibrators And Metabolism Controls.
| Device ID | K060480 |
| 510k Number | K060480 |
| Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Leah Van De Water |
| Correspondent | Leah Van De Water ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | CGR |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-23 |
| Decision Date | 2006-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750009053 | K060480 | 000 |