Panels › Clinical Chemistry › Product code NRH · Class 1
System, Breath Measurement
Regulation 862.1820
0510(k)s in 12 months (4 all time)
3recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in NRH
| Company | 510(k)s | Recalls |
|---|---|---|
| GET TESTED INTERNATIONAL AB | 0 | 3 |
| Micro Direct, Inc. | 2 | 0 |
| Enteron, Inc. | 1 | 0 |
| Vitalograph , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Sorbitol Intolerance Test Open, Classified |
NRH | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB SIBO Test Open, Classified |
NRH | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Lactose Intolerance Test Open, Classified |
NRH | None listed |
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