The following data is part of a premarket notification filed by Selfcare, Inc. with the FDA for Excel Ge Blood Glucose Test Strips & Code Strip.
| Device ID | K991480 |
| 510k Number | K991480 |
| Device Name: | EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP |
| Classification | Glucose Oxidase, Glucose |
| Applicant | SELFCARE, INC. 200 PROSPECT ST. Waltham, MA 02154 -3457 |
| Contact | Carol Adiletto |
| Correspondent | Carol Adiletto SELFCARE, INC. 200 PROSPECT ST. Waltham, MA 02154 -3457 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-28 |
| Decision Date | 1999-09-17 |
| Summary: | summary |