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 |