The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Alinity C Glucose Reagent Kit, Alinity C System.
| Device ID | K170316 |
| 510k Number | K170316 |
| Device Name: | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM |
| Classification | Hexokinase, Glucose |
| Applicant | Abbott Laboratories Dept. 09AA, Bldg CP1-3, 100 Abbott Park Road Abbott Park, IL 60064 |
| Contact | Noah Lermer |
| Correspondent | Noah Lermer Abbott Laboratories Dept. 09AA, Bldg CP1-3, 100 Abbott Park Road Abbott Park, IL 60064 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-01 |
| Decision Date | 2017-10-19 |
| Summary: | summary |