The following data is part of a premarket notification filed by Selfcare, Inc. with the FDA for Selfcare Blood Glucose Test Strips For The Exactech System.
| Device ID | K960053 |
| 510k Number | K960053 |
| Device Name: | SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | SELFCARE, INC. 200 PROSPECT ST. Waltham, MA 02154 -3457 |
| Contact | Carol A Adiletto |
| Correspondent | Carol A 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 | 1996-01-04 |
| Decision Date | 1996-06-28 |