The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Dhdl Slides, Vitros Chemistry Products Calibrator Kit 25, Vitros Chemistry Products Performace.
| Device ID | K042006 |
| 510k Number | K042006 |
| Device Name: | VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Darlene J Phillips |
| Correspondent | Darlene J Phillips Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | LBS |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-26 |
| Decision Date | 2004-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750001675 | K042006 | 000 |