The following data is part of a premarket notification filed by Ceragem Medisys Inc. with the FDA for Cera-chek 1070 Blood Glucose Monitoring System.
| Device ID | K131727 |
| 510k Number | K131727 |
| Device Name: | CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | CERAGEM MEDISYS INC. Cheonan Si, Chungcheongnam-do, KR 331-833 |
| Contact | Haksung Kim |
| Correspondent | Haksung Kim CERAGEM MEDISYS INC. Cheonan Si, Chungcheongnam-do, KR 331-833 |
| Product Code | LFR |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JQP |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-12 |
| Decision Date | 2014-02-28 |
| Summary: | summary |