The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros 5,1 Fs Chemistry System, Vitros Chemistry Products Dhdl Reagent Pack, Calibrator Kit 19, Fs Calibrator 1.
Device ID | K031924 |
510k Number | K031924 |
Device Name: | VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 |
Classification | Calibrator, Secondary |
Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Contact | Neil Greenberg |
Correspondent | Neil Greenberg ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Product Code | JIT |
Subsequent Product Code | JJE |
Subsequent Product Code | LBR |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-23 |
Decision Date | 2003-08-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10758750033201 | K031924 | 000 |
10758750012343 | K031924 | 000 |