The following data is part of a premarket notification filed by Yeongdong Pharmaceutical Corp. with the FDA for Uriscan S-300 Semi-automated Urine Chemistry Analyzer.
| Device ID | K980047 |
| 510k Number | K980047 |
| Device Name: | URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER |
| Classification | Automated Urinalysis System |
| Applicant | YEONGDONG PHARMACEUTICAL CORP. 55 NORTHERN BLVD, SUITE 410 Great Neck, NY 11021 |
| Contact | Thomas J Bouchard |
| Correspondent | Thomas J Bouchard YEONGDONG PHARMACEUTICAL CORP. 55 NORTHERN BLVD, SUITE 410 Great Neck, NY 11021 |
| Product Code | KQO |
| Subsequent Product Code | JIL |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-06 |
| Decision Date | 1998-06-10 |
| Summary: | summary |