DIALBUMIN
Indicator Method, Protein Or Albumin (urinary, Non-quant.)
EXOCELL, INC.
The following data is part of a premarket notification filed by Exocell, Inc. with the FDA for Dialbumin.
Pre-market Notification Details
| 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 |
Trademark Results [DIALBUMIN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIALBUMIN 73789872 1582331 Dead/Cancelled |
EXOCELL, INC. 1989-03-29 |
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