K011710 is an FDA 510(k) clearance for the OXOID PBP2 1 LATEX AGGLUTINATION TEST. This device is classified as a System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (Class II - Special Controls, product code MYI).
Submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on April 2, 2002, 302 days after receiving the submission on June 4, 2001.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K011710 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2001 |
| Decision Date | April 02, 2002 |
| Days to Decision | 302 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | MYI — System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |