The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur Ca 15-3 Assay.
Device ID | K192777 |
510k Number | K192777 |
Device Name: | ADVIA Centaur CA 15-3 Assay |
Classification | System, Test, Immunological, Antigen, Tumor |
Applicant | Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
Contact | Anoop Joy |
Correspondent | Anoop Joy Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
Product Code | MOI |
CFR Regulation Number | 866.6010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-30 |
Decision Date | 2019-11-22 |