The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Alinity C Ict Sample Diluent.
Device ID | K170320 |
510k Number | K170320 |
Device Name: | Alinity C ICT Sample Diluent |
Classification | Electrode, Ion-specific, Chloride |
Applicant | Abbott Laboratories Dept. 09AA, Bldg CP01-3, 100 Abbott Park Road Abbott Park, IL 60064 |
Contact | Zaman Khan |
Correspondent | Zaman Khan Abbott Laboratories Dept. 09AA, Bldg CP01-3, 100 Abbott Park Road Abbott Park, IL 60064 |
Product Code | CGZ |
Subsequent Product Code | CEM |
Subsequent Product Code | JGS |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-01 |
Decision Date | 2017-10-24 |
Summary: | summary |