K830220 is an FDA 510(k) clearance for the YELLOW IRIS TM. This device is classified as a Automated Urinalysis System (Class I - General Controls, product code KQO).
Submitted by Intl. Remote Imaging Systems (Mchenry, US). The FDA issued a Cleared decision on June 17, 1983, 144 days after receiving the submission on January 24, 1983.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 862.2900.
| 510(k) Number | K830220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1983 |
| Decision Date | June 17, 1983 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KQO — Automated Urinalysis System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2900 |