PROSPECT/GIARDIA
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
ALEXON BIOMEDICAL, INC.
The following data is part of a premarket notification filed by Alexon Biomedical, Inc. with the FDA for Prospect/giardia.
Pre-market Notification Details
| Device ID | K874849 |
| 510k Number | K874849 |
| Device Name: | PROSPECT/GIARDIA |
| Classification | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Applicant | ALEXON BIOMEDICAL, INC. 868 BAKER COURT Glen Ellyn, IL 60137 |
| Contact | Coles, Ph.d. |
| Correspondent | Coles, Ph.d. ALEXON BIOMEDICAL, INC. 868 BAKER COURT Glen Ellyn, IL 60137 |
| Product Code | KHW |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-25 |
| Decision Date | 1988-01-05 |
Trademark Results [PROSPECT/GIARDIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROSPECT/GIARDIA 73834819 1635255 Dead/Cancelled |
ALEXON BIOMEDICAL, INC. 1989-10-30 |
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