The following data is part of a premarket notification filed by Intl. Remote Imaging Systems with the FDA for Iristain Formula 2, Parts 1 And 2.
| Device ID | K893530 |
| 510k Number | K893530 |
| Device Name: | IRISTAIN FORMULA 2, PARTS 1 AND 2 |
| Classification | Stains, Microbiologic |
| Applicant | INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
| Contact | Fred Deindoerfer,phd |
| Correspondent | Fred Deindoerfer,phd INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
| Product Code | JTS |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-08 |
| Decision Date | 1989-06-13 |