The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostic Products Anti-hbs Controls.
| Device ID | K003112 |
| 510k Number | K003112 |
| Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Susan Werner |
| Correspondent | Susan Werner Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | JJX |
| Subsequent Product Code | MJX |
| Subsequent Product Code | MJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-04 |
| Decision Date | 2000-11-02 |