The following data is part of a premarket notification filed by Aalto Scientific, Ltd. with the FDA for Audit Microcontrols Linearity Drop Lq Blood Glucose.
| Device ID | K161874 |
| 510k Number | K161874 |
| Device Name: | Audit MicroControls Linearity DROP LQ Blood Glucose |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | AALTO SCIENTIFIC, LTD. 230 TECHNOLOGY PARKWAY Eatonton, GA 30642 |
| Contact | Robert Burda |
| Correspondent | Robert Burda AALTO SCIENTIFIC, LTD. 230 TECHNOLOGY PARKWAY Eatonton, GA 30642 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-08 |
| Decision Date | 2016-08-10 |
| Summary: | summary |