K812750 is an FDA 510(k) clearance for the IL 703, STAT SEPARATOR. This device is classified as a Unit, Filter, Membrane (Class I - General Controls, product code JRL).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on January 26, 1982, 119 days after receiving the submission on September 29, 1981.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K812750 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 1981 |
| Decision Date | January 26, 1982 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JRL — Unit, Filter, Membrane |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2050 |