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 | K140141 |
| 510k Number | K140141 |
| Device Name: | LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | CERAGEM MEDISYS INC. 16 JEONGIAL-GIL, SEONGGEO-EUP, SEOBUK-GU Cheonan, Chungcheongnam-do, KR 331-833 |
| Contact | Dana Moon |
| Correspondent | Dana Moon CERAGEM MEDISYS INC. 16 JEONGIAL-GIL, SEONGGEO-EUP, SEOBUK-GU Cheonan, Chungcheongnam-do, KR 331-833 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-07-03 |
| Summary: | summary |