The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur Cmv Igg And Advia Centaur Cmv Igg Quality Control.
Device ID | K181213 |
510k Number | K181213 |
Device Name: | ADVIA Centaur CMV IgG And ADVIA Centaur CMV IgG Quality Control |
Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
Applicant | Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown, NY 10591 |
Contact | Kira Gordon |
Correspondent | Kira Gordon Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown, NY 10591 |
Product Code | LFZ |
CFR Regulation Number | 866.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-07 |
Decision Date | 2018-07-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414246635 | K181213 | 000 |
00630414246482 | K181213 | 000 |
00630414588872 | K181213 | 000 |
00630414587448 | K181213 | 000 |