The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostic Products Ca 15-3 Calibrators,vitros Immunodiagnostic Products Ca 15-3 Reagent Pack.
Device ID | K983690 |
510k Number | K983690 |
Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK |
Classification | System, Test, Immunological, Antigen, Tumor |
Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Contact | Anne Zavertnik |
Correspondent | Anne Zavertnik Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
Product Code | MOI |
CFR Regulation Number | 866.6010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-21 |
Decision Date | 1999-02-02 |
Summary: | summary |