The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Lifescan Onetouch Ultra Control Solution.
| Device ID | K022769 |
| 510k Number | K022769 |
| Device Name: | LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BIONOSTICS, INC. 7 JACKSON RD. Devens, MA 01432 |
| Contact | Kathleen Storro |
| Correspondent | Kathleen Storro BIONOSTICS, INC. 7 JACKSON RD. Devens, MA 01432 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-21 |
| Decision Date | 2002-11-13 |
| Summary: | summary |