The following data is part of a premarket notification filed by Ceragem International, Inc. with the FDA for Labonacheck A1c.
| Device ID | K111128 |
| 510k Number | K111128 |
| Device Name: | LABONACHECK A1C |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | CERAGEM INTERNATIONAL, INC. 3699 WILSHIRE BLVD.,SUITE 930 Los Angeles, CA 90010 |
| Contact | Raymond Chung |
| Correspondent | Raymond Chung CERAGEM INTERNATIONAL, INC. 3699 WILSHIRE BLVD.,SUITE 930 Los Angeles, CA 90010 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-21 |
| Decision Date | 2012-09-13 |
| Summary: | summary |