The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Calibrator Kit 3.
Device ID | K161140 |
510k Number | K161140 |
Device Name: | VITROS Chemistry Products Calibrator Kit 3 |
Classification | Calibrator, Multi-analyte Mixture |
Applicant | ORTHO-CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DRIVE Rochester, NY 14626 -5101 |
Contact | Marlene Hanna |
Correspondent | Marlene Hanna ORTHO-CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DRIVE Rochester, NY 14626 -5101 |
Product Code | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-04-22 |
Decision Date | 2016-05-20 |
Summary: | summary |