The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products K+ Slides And Calibrator Kit 2.
Device ID | K073157 |
510k Number | K073157 |
Device Name: | VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 |
Classification | Electrode, Ion Specific, Potassium |
Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Contact | Marlene Hanna |
Correspondent | Marlene Hanna Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Product Code | CEM |
CFR Regulation Number | 862.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-08 |
Decision Date | 2007-12-07 |
Summary: | summary |