The following data is part of a premarket notification filed by In Wha Pharmaceutical Co., Ltd. with the FDA for Urotest Gph.
| Device ID | K912244 |
| 510k Number | K912244 |
| Device Name: | UROTEST GPH |
| Classification | Atomic Absorption, Lithium |
| Applicant | IN WHA PHARMACEUTICAL CO., LTD. BUK-KU CHUNGCHUN-DONG 234-1 Korea, KR |
| Product Code | JII |
| CFR Regulation Number | 862.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-21 |
| Decision Date | 1991-11-22 |