K820712 is an FDA 510(k) clearance for the SEPCOR UNIT COLLECTION MONITOR. This device is classified as a Device, Blood Mixing And Blood Weighing (Class I - General Controls, product code KSQ).
Submitted by Separation Science Corp. (Walker, US). The FDA issued a Cleared decision on May 7, 1982, 53 days after receiving the submission on March 15, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9195.
| 510(k) Number | K820712 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 1982 |
| Decision Date | May 07, 1982 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KSQ — Device, Blood Mixing And Blood Weighing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.9195 |