The following data is part of a premarket notification filed by Exocell, Inc. with the FDA for Glycacor.
Device ID | K980888 |
510k Number | K980888 |
Device Name: | GLYCACOR |
Classification | Assay, Glycosylated Hemoglobin |
Applicant | EXOCELL, INC. 3508 MARKET ST., SUITE 420 Philadelphia, PA 19104 |
Contact | Margo P Cohen |
Correspondent | Margo P Cohen EXOCELL, INC. 3508 MARKET ST., SUITE 420 Philadelphia, PA 19104 |
Product Code | LCP |
CFR Regulation Number | 864.7470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-09 |
Decision Date | 1998-08-13 |