K811523 is an FDA 510(k) clearance for the PLASMA FLEX. This device is classified as a Container, Empty, For Collection & Processing Of Blood & Blood Components (Class II - Special Controls, product code KSR).
Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1981, 103 days after receiving the submission on May 29, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.9100.
| 510(k) Number | K811523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1981 |
| Decision Date | September 09, 1981 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KSR — Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9100 |