The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros Chemistry Products C3 And Cr Reagent, Calibrator Kit 20, Protein Performance Verifiers I, Ii, And Iii.
Device ID | K042494 |
510k Number | K042494 |
Device Name: | VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III |
Classification | Complement C3, Antigen, Antiserum, Control |
Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Contact | Darlene J Phillips |
Correspondent | Darlene J Phillips ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Product Code | CZW |
Subsequent Product Code | DBI |
Subsequent Product Code | JIT |
Subsequent Product Code | JJX |
CFR Regulation Number | 866.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-14 |
Decision Date | 2004-10-19 |
Summary: | summary |