The following data is part of a premarket notification filed by Arlington Scientific, Inc. with the FDA for Asimanager - At.
| Device ID | K111356 |
| 510k Number | K111356 |
| Device Name: | ASIMANAGER - AT |
| Classification | Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Applicant | ARLINGTON SCIENTIFIC, INC. 1840 NORTH TECHNOLOGY DR. Springville, UT 84663 |
| Contact | David Binks |
| Correspondent | David Binks ARLINGTON SCIENTIFIC, INC. 1840 NORTH TECHNOLOGY DR. Springville, UT 84663 |
| Product Code | JQT |
| CFR Regulation Number | 862.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2011-11-09 |
| Summary: | summary |