K943463 is an FDA 510(k) clearance for the THE YELLOW IRIS. This device is classified as a Automated Urinalysis System (Class I - General Controls, product code KQO).
Submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on September 20, 1994, 64 days after receiving the submission on July 18, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2900.
| 510(k) Number | K943463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1994 |
| Decision Date | September 20, 1994 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | KQO — Automated Urinalysis System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2900 |