The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Atellica Im Total Hcg (thcg).
Device ID | K172322 |
510k Number | K172322 |
Device Name: | Atellica IM Total HCG (ThCG) |
Classification | Visual, Pregnancy Hcg, Prescription Use |
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 | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-01 |
Decision Date | 2018-03-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414600079 | K172322 | 000 |
00630414600062 | K172322 | 000 |
00630414600055 | K172322 | 000 |
00630414600048 | K172322 | 000 |
00630414600031 | K172322 | 000 |
00630414600024 | K172322 | 000 |
00630414294254 | K172322 | 000 |