The following data is part of a premarket notification filed by Polymedco, Inc. with the FDA for Glyca-direct Fructosamine.
| Device ID | K023654 |
| 510k Number | K023654 |
| Device Name: | GLYCA-DIRECT FRUCTOSAMINE |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Contact | Helen Landicho |
| Correspondent | Helen Landicho POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-30 |
| Decision Date | 2003-05-02 |