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 | K983726 |
510k Number | K983726 |
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 | 1998-10-22 |
Decision Date | 1998-11-25 |
Summary: | summary |