K162150 is an FDA 510(k) clearance for the BreathID Hp Lab System. This device is classified as a Test, Urea (breath Or Blood) (Class I - General Controls, product code MSQ).
Submitted by Exalenz Bioscience , Ltd. (Modiin, IL). The FDA issued a Cleared decision on October 31, 2016, 90 days after receiving the submission on August 2, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K162150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2016 |
| Decision Date | October 31, 2016 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MSQ - Test, Urea (breath Or Blood) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |