The following data is part of a premarket notification filed by Oxoid, Ltd. with the FDA for Oxoid Pbp2 1 Latex Agglutination Test.
| Device ID | K011710 |
| 510k Number | K011710 |
| Device Name: | OXOID PBP2 1 LATEX AGGLUTINATION TEST |
| Classification | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| Applicant | OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
| Contact | A. Hollingsworth |
| Correspondent | A. Hollingsworth OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
| Product Code | MYI |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-04 |
| Decision Date | 2002-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05032384096442 | K011710 | 000 |