The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Lifescan Surestep Pro Glucose Control/linearity Solutions.
| Device ID | K971014 |
| 510k Number | K971014 |
| Device Name: | LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Contact | Judy Martin |
| Correspondent | Judy Martin LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-20 |
| Decision Date | 1997-04-23 |
| Summary: | summary |