The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Surestep Blood Glucose Monitoring System.
| Device ID | K984261 |
| 510k Number | K984261 |
| Device Name: | SURESTEP BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | LIFESCAN, INC. 700 THIRTEENTH ST. NW Washington, DC 20005 |
| Contact | Roger Thies |
| Correspondent | Roger Thies LIFESCAN, INC. 700 THIRTEENTH ST. NW Washington, DC 20005 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-27 |
| Decision Date | 1999-05-21 |
| Summary: | summary |