K011668 is an FDA 510(k) clearance for the VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI. This device is classified as a Test, Urea (breath Or Blood) (Class I - General Controls, product code MSQ).
Submitted by Oridion Medical 1987 , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on July 9, 2001, 53 days after receiving the submission on May 17, 2001.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K011668 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2001 |
| Decision Date | July 09, 2001 |
| Days to Decision | 53 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 |