The following data is part of a premarket notification filed by Exocell, Inc. with the FDA for Glycaben.
Device ID | K893453 |
510k Number | K893453 |
Device Name: | GLYCABEN |
Classification | Assay, Glycosylated Hemoglobin |
Applicant | EXOCELL, INC. 3508 MARKET ST., SUITE 420 Philadelphia, PA 19104 |
Contact | Cohen, Md |
Correspondent | Cohen, Md 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 | 1989-05-03 |
Decision Date | 1989-10-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() GLYCABEN 73835891 1642560 Dead/Cancelled |
EXOCELL, INC. 1989-11-03 |