K874207 is an FDA 510(k) clearance for the THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION. This device is classified as a Light, Microscope (Class I - General Controls, product code IBJ).
Submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on January 5, 1988, 82 days after receiving the submission on October 15, 1987.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3600.
| 510(k) Number | K874207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1987 |
| Decision Date | January 05, 1988 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | IBJ — Light, Microscope |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3600 |