K132429 is an FDA 510(k) clearance for the SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET. This device is classified as a Separator, Automated, Blood Cell And Plasma, Therapeutic.
Submitted by Terumobct, Inc. (Lakewood, US). The FDA issued a Cleared decision on December 6, 2013, 123 days after receiving the submission on August 5, 2013.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K132429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2013 |
| Decision Date | December 06, 2013 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LKN — Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Device Class | — |