The following data is part of a premarket notification filed by American Healthcare Inc. with the FDA for Easygluco Igm-0002 G2.
| Device ID | K043512 |
| 510k Number | K043512 |
| Device Name: | EASYGLUCO IGM-0002 G2 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | AMERICAN HEALTHCARE INC. 304 PARK AVENUE SOUTH SUITE 218 New York, NY 10010 -4301 |
| Contact | Edward Letko |
| Correspondent | Edward Letko AMERICAN HEALTHCARE INC. 304 PARK AVENUE SOUTH SUITE 218 New York, NY 10010 -4301 |
| 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 | 2004-12-20 |
| Decision Date | 2005-04-08 |
| Summary: | summary |