The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binax Legionella Urinary Antigen Eia.
| Device ID | K934965 |
| 510k Number | K934965 |
| Device Name: | BINAX LEGIONELLA URINARY ANTIGEN EIA |
| Classification | Legionella, Spp., Elisa |
| Applicant | BINAX, INC. 217 READ ST. Portland, ME 04103 |
| Contact | Carolyn E Lawson |
| Correspondent | Carolyn E Lawson BINAX, INC. 217 READ ST. Portland, ME 04103 |
| Product Code | MJH |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-15 |
| Decision Date | 1994-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811877010767 | K934965 | 000 |
| 10811877010460 | K934965 | 000 |