510(k) K121905
- Device
- ALERE PBP2A TEST
- Applicant
- ALERE SCARBOROUGH, INC
- 510(k) number
- K121905
- Product code
- MYI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-07-26
- Date received
- 2012-06-29
- Regulation
- 866.1640
- Classification name
- System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Angela Drysdale
- Address
- 10 Southgate Rd. Scarborough ME US 04074 04074
FDA Registration Numbers#
- 3003750284
- 8010096
- 1221359
- 3017662853
- 8020667
Source Documents#
Other 510(k) Records For Product Code MYI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140619 | MECA XPRESSFISH | Advandx, Inc. | 2014-10-10 |
| K133851 | ALERE PBP2A SA/CONS CULTURE COLONY TEST | Alere Scarborough, Inc. | 2014-09-03 |
| K090301 | BINAXNOW PBP2A TEST, MODEL 890-000 | Binax, Inc. | 2010-04-14 |
| K091766 | CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 | Binax, Inc. | 2010-02-24 |
| K062864 | MASTALEX -MRSA, MODEL RST501 | Mast Group , Ltd. | 2006-10-18 |
| K011710 | OXOID PBP2 1 LATEX AGGLUTINATION TEST | Oxoid , Ltd. | 2002-04-02 |
| K011400 | MRSA-SCREEN | Denka Seiken'S | 2002-03-27 |
| K010858 | VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION | Id Biomedical Corp. | 2001-05-24 |
| K990640 | VELOGENE RAPID MRSA IDENTIFICATION ASSAY | Id Biomedical Corp. | 1999-07-09 |
Legacy Summary#
summary
FDA Review#
Decision Summary