The following data is part of a premarket notification filed by Infopia Co., Ltd with the FDA for Clover A1c/glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023.
| Device ID | K082275 |
| 510k Number | K082275 |
| Device Name: | CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | INFOPIA CO., LTD 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Maria F Griffin |
| Correspondent | Maria F Griffin INFOPIA CO., LTD 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-11 |
| Decision Date | 2010-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860394001270 | K082275 | 000 |
| 00850006113040 | K082275 | 000 |
| 00850006113033 | K082275 | 000 |
| 00850006113026 | K082275 | 000 |