The following data is part of a premarket notification filed by Ceragem Medisys Inc. with the FDA for Labonacheck Gluppy Blood Glucose Monitoring System.
| Device ID | K102751 |
| 510k Number | K102751 |
| Device Name: | LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | CERAGEM MEDISYS INC. 3699 WILSHIRE BLVD., STE 930 Los Angeles, CA 90010 |
| Contact | Grace Kim |
| Correspondent | Grace Kim CERAGEM MEDISYS INC. 3699 WILSHIRE BLVD., STE 930 Los Angeles, CA 90010 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-23 |
| Decision Date | 2013-02-11 |
| Summary: | summary |