The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitro Chemistry Products Eco2 Slide & Calibrator Kit 2.
| Device ID | K001133 |
| 510k Number | K001133 |
| Device Name: | VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Marlene Shulman |
| Correspondent | Marlene Shulman Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-04-24 |