The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 And Tdm Performance Verifiers I, Ii And Iii.
| Device ID | K043384 |
| 510k Number | K043384 |
| Device Name: | VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III |
| Classification | Enzymatic Radiochemical Assay, Tobramycin |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Carey A Mayo |
| Correspondent | Carey A Mayo Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | LDO |
| Subsequent Product Code | DIF |
| Subsequent Product Code | DLJ |
| CFR Regulation Number | 862.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-09 |
| Decision Date | 2005-02-07 |
| Summary: | summary |