The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros Immunodiagnostic Products Anti-hbc Controls.
| Device ID | K033127 |
| 510k Number | K033127 |
| Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Sarah Parsons |
| Correspondent | Sarah Parsons ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2003-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750001231 | K033127 | 000 |