The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros Immunodiagnostic Products Folate Range Verifiers.
| Device ID | K011463 |
| 510k Number | K011463 |
| Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Darlene J Phillips |
| Correspondent | Darlene J Phillips ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-14 |
| Decision Date | 2001-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750000944 | K011463 | 000 |