The following data is part of a premarket notification filed by International Remote Imaging Systems with the FDA for Irispec Urine Chemistry Control Part A And B.
| Device ID | K945913 |
| 510k Number | K945913 |
| Device Name: | IRISPEC URINE CHEMISTRY CONTROL PART A AND B |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | INTERNATIONAL REMOTE IMAGING SYSTEMS 9825 DE SOTO AVE. Chartsworth, CA 91311 |
| Contact | Sanford Widran |
| Correspondent | Sanford Widran INTERNATIONAL REMOTE IMAGING SYSTEMS 9825 DE SOTO AVE. Chartsworth, CA 91311 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-02 |
| Decision Date | 1995-04-05 |