The following data is part of a premarket notification filed by Intl. Remote Imaging Systems with the FDA for Iri Spec Urinalysis Control.
| Device ID | K832713 |
| 510k Number | K832713 |
| Device Name: | IRI SPEC URINALYSIS CONTROL |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | INTL. REMOTE IMAGING SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-12 |
| Decision Date | 1983-12-22 |