The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Co2 Dt Slides; Vitros Chemmistry Products Dt Calibrator Kit, Models Co2 Dt Slides, 172 0002;.
| Device ID | K093611 |
| 510k Number | K093611 |
| Device Name: | VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. MC 00882 Rochester, NY 14626 -5101 |
| Contact | Marlene A Hanna |
| Correspondent | Marlene A Hanna Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. MC 00882 Rochester, NY 14626 -5101 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-23 |
| Decision Date | 2010-04-15 |
| Summary: | summary |