K141328 is an FDA 510(k) clearance for the QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS. This device is classified as a Extractable Antinuclear Antibody, Antigen And Control (Class II - Special Controls, product code LLL).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on February 12, 2015, 267 days after receiving the submission on May 21, 2014.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K141328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2014 |
| Decision Date | February 12, 2015 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LLL — Extractable Antinuclear Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |