Binaxnow PBP2A Test, Model 890-000
FDA 510(k) K090301 · Binax, Inc.
510(k) numberK090301
Submission
- Device name
- Binaxnow PBP2A Test, Model 890-000
- Applicant
- Binax, Inc.
Scarborough, ME, US - Received
- February 6, 2009
- Decision date
- April 14, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K121905 | Alere PBP2A TestMYI · Special | Alere Scarborough, Inc. | 07/26/2012SE |
| 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 |
More from Id Biomedical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K091766 | Clearview Exact PBP2A Test, Model 891-000MYI · Traditional | 02/24/2010SE |
| K090964 | Binaxnox Staphylococcus Aureus TestJWX · Traditional | 12/16/2009SE |
| K091489 | Clearview Advanced Strep a , Model 737-430GTY · Traditional | 09/04/2009SE |
| K083744 | Binaxnow Malaria Positive Control Kit, Model 665-010MJZ · Traditional | 09/01/2009SE |
| K092223 | Modification to: Binaxnow Influenza a & B TestPSZ · Special | 08/12/2009SE |
| K080003 | Binaxnow G6PD TestJBF · Traditional | 10/23/2008SE |
| K062109 | Binaxnow Influenza a & B TestPSZ · Traditional | 11/09/2006SE |
| K053126 | Binaxnow Influenza a & B TestPSZ · Traditional | 11/30/2005SE |
| K041049 | Binaxnow Influenza a & B TestPSZ · Traditional | 08/10/2004SE |
| K032166 | Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack…GQG · Traditional | 10/21/2003SE |
Questions and answers
When was Binaxnow PBP2A Test, Model 890-000 cleared by the FDA?
Binaxnow PBP2A Test, Model 890-000 (K090301) received a 510(k) decision of Substantially Equivalent on April 14, 2010, 432 days after the submission was received.
What is the product code of K090301?
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.