510(k) K141757
- Device
- ALERE I STREP A
- Applicant
- ALERE SCARBOROUGH, INC
- 510(k) number
- K141757
- Product code
- PGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-03-31
- Date received
- 2014-06-30
- Regulation
- 866.2680
- Classification name
- Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- 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#
- 3005360469
- 2023365
- 3003018722
- 1221359
- 1528450
- 3004530258
- 3002773840
- 3012918440
- 3019946577
- 1524213
- 3016838963
- 9610126
- 3009613136
- 3004141078
- 3003795116
- 3012494290
- 2243471
Source Documents#
Other 510(k) Records For Product Code PGX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201269 | Accula Strep A Test | Mesa Biotech, Inc. | 2020-11-09 |
| K183366 | GenePOC Strep A | Genepoc, Inc. | 2019-03-06 |
| K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit | Alere Scarborough, Inc. | 2018-05-02 |
| K173398 | Xpert Xpress Strep A | Cepheid | 2018-04-26 |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | Luminex Corporation | 2017-10-30 |
| K172126 | Xpert Xpress Strep A | Cepheid | 2017-09-25 |
| K162274 | Solana Strep Complete Assay | Quidel Corporation | 2016-10-25 |
| K150868 | Solana GAS Assay, Solana instrument | Quidel Corporation | 2015-06-23 |
| K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack | Focus Diagnostics, Inc. | 2015-03-18 |
| K141338 | LIAT STREP A ASSAY | Iquum, Inc. | 2014-11-04 |
| K141173 | AMPLIVUE GAS ASSAY | Quidel Corporation | 2014-07-24 |
| DEN140005 | LYRA DIRECT STREP ASSAY | Quidel Corporation | 2014-04-16 |
Legacy Summary#
summary
FDA Review#
Decision Summary