K972146 is an FDA 510(k) clearance for the QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS. This device is classified as a Helicobacter Pylori (Class I — General Controls, product code LYR).
Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on July 8, 1997, 29 days after receiving the submission on June 9, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K972146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1997 |
| Decision Date | July 08, 1997 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LYR — Helicobacter Pylori |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3110 |