The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Mg Slide, Vitros Chemistry Products Calibrator Kit 1.
Device ID | K023876 |
510k Number | K023876 |
Device Name: | VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 |
Classification | Calibrator, Multi-analyte Mixture |
Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Contact | Marlene A Hanna |
Correspondent | Marlene A Hanna Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Product Code | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-21 |
Decision Date | 2002-12-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10758750004621 | K023876 | 000 |
10758750000265 | K023876 | 000 |