The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Selfcheck Gluco.
| Device ID | K061528 |
| 510k Number | K061528 |
| Device Name: | SELFCHECK GLUCO |
| Classification | Glucose Oxidase, Glucose |
| Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST., SCIENCE PARK P.O.B. 527 Rehovot, IL 76100 |
| Contact | Alex Gonorovsky |
| Correspondent | Alex Gonorovsky CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST., SCIENCE PARK P.O.B. 527 Rehovot, IL 76100 |
| Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-02 |
| Decision Date | 2006-09-22 |
| Summary: | summary |