Alere PBP2A Test
FDA 510(k) K121905 · Alere Scarborough, Inc.
510(k) numberK121905
Submission
- Device name
- Alere PBP2A Test
- Applicant
- Alere Scarborough, Inc.
Scarborough, ME, US - Received
- June 29, 2012
- Decision date
- July 26, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MYI – System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code MYI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140619 | Meca XpressfishMYI · Traditional | Advandx, Inc. | 10/10/2014SE |
| K133851 | Alere PBP2A Sa/Cons Culture Colony TestMYI · Traditional | Alere Scarborough, Inc. | 09/03/2014SE |
| K090301 | Binaxnow PBP2A Test, Model 890-000MYI · Traditional | Binax, Inc. | 04/14/2010SE |
| K091766 | Clearview Exact PBP2A Test, Model 891-000MYI · Traditional | Binax, Inc. | 02/24/2010SE |
| K062864 | Mastalex -Mrsa, Model RST501MYI · Traditional | Mast Group , Ltd. | 10/18/2006SE |
| K011710 | Oxoid PBP2 1 Latex Agglutination TestMYI · Traditional | Oxoid , Ltd. | 04/02/2002SE |
| K011400 | Mrsa-ScreenMYI · Traditional | Denka Seiken'S | 03/27/2002SE |
| K010858 | Velogene Genomic Identification Assay for Mrsa with One-Step DetectionMYI · Traditional | Id Biomedical Corp. | 05/24/2001SE |
| K990640 | Velogene Rapid Mrsa Identification AssayMYI · Traditional | Id Biomedical Corp. | 07/09/1999SE |
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Questions and answers
When was Alere PBP2A Test cleared by the FDA?
Alere PBP2A Test (K121905) received a 510(k) decision of Substantially Equivalent on July 26, 2012, 27 days after the submission was received.
What is the product code of K121905?
The FDA product code is MYI – System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies, a Class II (moderate risk) device regulated under 21 CFR 866.1640.