K821503 is an FDA 510(k) clearance for the IRIS URINE STAIN. This device is classified as a Crystal Violet For Histology (Class I - General Controls, product code ICF).
Submitted by Intl. Remote Imaging Systems (Mchenry, US). The FDA issued a Cleared decision on June 3, 1982, 15 days after receiving the submission on May 19, 1982.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K821503 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 1982 |
| Decision Date | June 03, 1982 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | ICF — Crystal Violet For Histology |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |