The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binax Now Legionella Urinary Antigen Test Model 852-020 And Binax Now Leg Ionella Urinary Antigen Control Kit Model 8522.
| Device ID | K982238 |
| 510k Number | K982238 |
| Device Name: | BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 |
| Classification | Legionella, Spp., Elisa |
| Applicant | BINAX, INC. 217 READ ST. Portland, ME 04103 |
| Contact | Pamela S Angell |
| Correspondent | Pamela S Angell 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 | 1998-06-25 |
| Decision Date | 1998-08-21 |
| Summary: | summary |