K912244 is an FDA 510(k) clearance for the UROTEST GPH. This device is classified as a Atomic Absorption, Lithium (Class II - Special Controls, product code JII).
Submitted by In Wha Pharmaceutical Co., Ltd. (Korea, KR). The FDA issued a Cleared decision on November 22, 1991, 185 days after receiving the submission on May 21, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3560.
| 510(k) Number | K912244 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1991 |
| Decision Date | November 22, 1991 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JII — Atomic Absorption, Lithium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3560 |