The following data is part of a premarket notification filed by Selfcare, Inc. with the FDA for One Touch Ultra Blood Glucose Monitoring System.
| Device ID | K002134 |
| 510k Number | K002134 |
| Device Name: | ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | SELFCARE, INC. 200 PROSPECT ST. Waltham, MA 02154 -3457 |
| Contact | Carol A Adiletto, M.s. |
| Correspondent | Carol A Adiletto, M.s. SELFCARE, INC. 200 PROSPECT ST. Waltham, MA 02154 -3457 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-14 |
| Decision Date | 2000-08-07 |