The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Crea Slides,model# 6802584, Vitros Chemistry Products Calibrator Kit 1,model#1882208.
Device ID | K063591 |
510k Number | K063591 |
Device Name: | VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208 |
Classification | Enzymatic Method, Creatinine |
Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DRIVE MC881 Rochester, NY 14626 -5101 |
Contact | Michael M Byrne |
Correspondent | Michael M Byrne Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DRIVE MC881 Rochester, NY 14626 -5101 |
Product Code | JFY |
CFR Regulation Number | 862.1225 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-01 |
Decision Date | 2006-12-15 |
Summary: | summary |