The following data is part of a premarket notification filed by Inverness Medical Professional Diagnostics with the FDA for Modification To: Binax Now Legionella Urinary Antigen Test, #852-000,852-012.
| Device ID | K070522 |
| 510k Number | K070522 |
| Device Name: | MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 |
| Classification | Legionella, Spp., Elisa |
| Applicant | INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 10 SOUTHGATE RD. Scarborough, ME 04074 |
| Contact | Karen Mortimer |
| Correspondent | Karen Mortimer INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 10 SOUTHGATE RD. Scarborough, ME 04074 |
| Product Code | MJH |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-23 |
| Decision Date | 2007-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811877011054 | K070522 | 000 |
| 10811877011023 | K070522 | 000 |
| 10811877010491 | K070522 | 000 |
| 10811877010477 | K070522 | 000 |