The following data is part of a premarket notification filed by Exocell, Inc. with the FDA for Dialbumin.
Device ID | K891544 |
510k Number | K891544 |
Device Name: | DIALBUMIN |
Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
Applicant | EXOCELL, INC. 3508 MARKET ST., SUITE 420 Philadelphia, PA 19104 |
Contact | Cohen, M.d. |
Correspondent | Cohen, M.d. EXOCELL, INC. 3508 MARKET ST., SUITE 420 Philadelphia, PA 19104 |
Product Code | JIR |
CFR Regulation Number | 862.1645 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-17 |
Decision Date | 1989-06-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DIALBUMIN 73789872 1582331 Dead/Cancelled |
EXOCELL, INC. 1989-03-29 |