The following data is part of a premarket notification filed by Ihara Medics U.s., Inc. with the FDA for Keto-340 Ii.
| Device ID | K912373 |
| 510k Number | K912373 |
| Device Name: | KETO-340 II |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | IHARA MEDICS U.S., INC. 25030 AVENUE TIBBITS, UNIT K Valencia, CA 91355 |
| Contact | Leonard Spolter |
| Correspondent | Leonard Spolter 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 | 1991-05-29 |
| Decision Date | 1991-07-01 |