The following data is part of a premarket notification filed by Ihara Medics U.s., Inc. with the FDA for Ketorex Sanwa Standards.
| Device ID | K903365 |
| 510k Number | K903365 |
| Device Name: | KETOREX SANWA STANDARDS |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | IHARA MEDICS U.S., INC. 25030 AVENUE TIBBITS, UNIT K Valencia, CA 91355 |
| Contact | Spolter, Phd |
| Correspondent | Spolter, Phd IHARA MEDICS U.S., INC. 25030 AVENUE TIBBITS, UNIT K Valencia, CA 91355 |
| Product Code | JIN |
| CFR Regulation Number | 862.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-26 |
| Decision Date | 1990-12-20 |