The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High Control.
| Device ID | K000239 |
| 510k Number | K000239 |
| Device Name: | GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 -1562 |
| Contact | Barbara Pizza |
| Correspondent | Barbara Pizza GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 -1562 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-27 |
| Decision Date | 2000-03-21 |