The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, Calibrators.
| Device ID | K013899 |
| 510k Number | K013899 |
| Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS |
| Classification | Radioassay, Vitamin B12 |
| Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Marlene A Shulman |
| Correspondent | Marlene A Shulman ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2002-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750009367 | K013899 | 000 |
| 10758750009138 | K013899 | 000 |
| 10758750008476 | K013899 | 000 |