ALERE PBP2A TEST
FDA 510(k) clearance K121905 · decided 2012-07-26
Clearance details
- K-number
- K121905
- Device name
- ALERE PBP2A TEST
- Applicant
- Alere Scarborough, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-06-29
- Decision date
- 2012-07-26
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- MYI
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Scarborough, ME, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MECA XPRESSFISH (K140619) | Advandx, Inc. | 2014-10-10 |
| ALERE PBP2A SA/CONS CULTURE COLONY TEST (K133851) | Alere Scarborough, Inc. | 2014-09-03 |
| BINAXNOW PBP2A TEST, MODEL 890-000 (K090301) | Binax, Inc. | 2010-04-14 |
| CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 (K091766) | Binax, Inc. | 2010-02-24 |
| MASTALEX -MRSA, MODEL RST501 (K062864) | Mast Group , Ltd. | 2006-10-18 |
| OXOID PBP2 1 LATEX AGGLUTINATION TEST (K011710) | Oxoid , Ltd. | 2002-04-02 |
| MRSA-SCREEN (K011400) | Denka Seiken'S | 2002-03-27 |
| VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION (K010858) | Id Biomedical Corp. | 2001-05-24 |
| VELOGENE RAPID MRSA IDENTIFICATION ASSAY (K990640) | Id Biomedical Corp. | 1999-07-09 |
Recalls involving this device
No recalls on record reference this clearance.