The following data is part of a premarket notification filed by Yd Diagnostics Corp. with the FDA for Uriscan Optima.
| Device ID | K141874 |
| 510k Number | K141874 |
| Device Name: | URISCAN OPTIMA |
| Classification | Automated Urinalysis System |
| Applicant | YD DIAGNOSTICS CORP. #821 SAMIL PLAZA 837-26 YEUKSAM-DONG Gangnam-gu, Seoul, KR 135-768 |
| Contact | Yang Ho Dong |
| Correspondent | Yang Ho Dong YD DIAGNOSTICS CORP. #821 SAMIL PLAZA 837-26 YEUKSAM-DONG Gangnam-gu, Seoul, KR 135-768 |
| Product Code | KQO |
| Subsequent Product Code | JFY |
| Subsequent Product Code | JIR |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-11 |
| Decision Date | 2015-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806125680224 | K141874 | 000 |