The following data is part of a premarket notification filed by Neo Diagnostics, Inc with the FDA for Ketochecks.
| Device ID | K033114 |
| 510k Number | K033114 |
| Device Name: | KETOCHECKS |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | NEO DIAGNOSTICS, INC 10532 WALKER ST. SUITE B Cypress, CA 90630 |
| Contact | Sung Pyo |
| Correspondent | Sung Pyo NEO DIAGNOSTICS, INC 10532 WALKER ST. SUITE B Cypress, CA 90630 |
| Product Code | JIN |
| CFR Regulation Number | 862.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2004-04-26 |
| Summary: | summary |