The following data is part of a premarket notification filed by Sa Scientific Ltd. with the FDA for Sas Legionella Test, Sas Legionella Dipstick Test.
| Device ID | K061496 |
| 510k Number | K061496 |
| Device Name: | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST |
| Classification | Legionella, Spp., Elisa |
| Applicant | SA SCIENTIFIC LTD. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Contact | Ricardo R Martinez |
| Correspondent | Ricardo R Martinez SA SCIENTIFIC LTD. 4919 GOLDEN QUAIL San Antonio, TX 78240 |
| Product Code | MJH |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-31 |
| Decision Date | 2007-06-28 |
| Summary: | summary |