The following data is part of a premarket notification filed by Yd Diagnostics with the FDA for Uriscan Optima Ii Urine Analyzer.
| Device ID | K050801 |
| 510k Number | K050801 |
| Device Name: | URISCAN OPTIMA II URINE ANALYZER |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | YD DIAGNOSTICS 707 FOOTHILL BLVD. STE. 200 La Canada, CA 91011 |
| Contact | Jerri Hoi |
| Correspondent | Jerri Hoi YD DIAGNOSTICS 707 FOOTHILL BLVD. STE. 200 La Canada, CA 91011 |
| Product Code | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | KQO |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-30 |
| Decision Date | 2005-04-20 |