The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Ast Slide And Chemistry Products Calibrator Kit 3.
Device ID | K001679 |
510k Number | K001679 |
Device Name: | VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 |
Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Contact | Marlene A Shulman |
Correspondent | Marlene A Shulman Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Product Code | CIT |
Subsequent Product Code | CIF |
Subsequent Product Code | CIQ |
Subsequent Product Code | CIS |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-01 |
Decision Date | 2000-06-28 |