The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Dldl Reagent, Calibrator Kit 19, Fs Calibrator 1 And Performance Verifiers I And Ii.
Device ID | K041720 |
510k Number | K041720 |
Device Name: | VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II |
Classification | System, Test, Low Density, Lipoprotein |
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 | MRR |
Subsequent Product Code | JIT |
Subsequent Product Code | JJX |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-06-24 |
Decision Date | 2004-08-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10758750006793 | K041720 | 000 |
10758750004577 | K041720 | 000 |
10758750004317 | K041720 | 000 |