Panels › Clinical Chemistry › Product code CEN · Class 1
Dye-Indicator, Ph (Urinary, Non-Quantitative)
Regulation 862.1550
0510(k)s in 12 months (11 all time)
4recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in CEN
| Company | 510(k)s | Recalls |
|---|---|---|
| Common Sense , Ltd. | 2 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 2 |
| Abbott Laboratories | 1 | 0 |
| Changchun Wancheng Bio-Electron Co., Ltd. | 0 | 1 |
| DFI Co., Ltd. | 0 | 1 |
| Germaine Laboratories, Inc. | 1 | 0 |
| Helena Laboratories | 1 | 0 |
| Kyoto Diagnostics, Inc. | 1 | 0 |
| Lenal Creative Approaches, Inc. | 1 | 0 |
| Litmus Concepts, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2026 | DFI Co., Ltd. One Step pH in vitro diagnostic test
REF: 31I4P Open, Classified |
CEN | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. Vivoo pH Test Open, Classified |
CEN | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Organic Acids Profile Test Large Open, Classified |
CEN | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Vaginal PH Test Open, Classified |
CEN | None listed |
| Oct 23, 2023 | Universal Meditech Inc. HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP Open, Classified |
CEN | None listed |
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