Company ยท US
Alere Scarborough, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2019. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 5 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 3 |
| MYI | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies | 2 |
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 |
| JBF | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | 1 |
| OAM | Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | 1 |
| OOI | Real Time Nucleic Acid Amplification System | 1 |
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | 1 |
| QFA | Assay For Detection Of Proteases In Chronic Wounds | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 2, 2019 | DEN180014 | WOUNDCHEK Bacterial Status Alere Scarborough, Inc. | QFA |
| Mar 18, 2019 | K190204 | ID NOW Influenza A & B 2 Alere Scarborough, Inc. | OZE |
| Aug 8, 2018 | K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader Alere Scarborough, Inc. | PSZ |
| May 2, 2018 | K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit Alere Scarborough, Inc. | PGX |
| Jan 26, 2018 | K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 Alere Scarborough, Inc. | OCC |
| Dec 13, 2017 | K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit Alere Scarborough, Inc. | PSZ |
| Sep 29, 2017 | K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit Alere Scarborough, Inc. | OCC |
| Apr 10, 2017 | K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit Alere Scarborough, Inc. | PSZ |
| Dec 21, 2016 | K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument Alere Scarborough, Inc. | OCC |
| Aug 18, 2016 | K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit Alere Scarborough, Inc. | OCC |
| Jun 17, 2016 | K161364 | BinaxNOW G6PD Test Alere Scarborough, Inc. | JBF |
| Jul 28, 2015 | K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit Alere Scarborough, Inc. | OCC |
| Jul 16, 2015 | K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A Alere Scarborough, Inc. | OOI |
| Mar 31, 2015 | K141757 | ALERE I STREP A Alere Scarborough, Inc. | PGX |
| Sep 3, 2014 | K133851 | ALERE PBP2A SA/CONS CULTURE COLONY TEST Alere Scarborough, Inc. | MYI |
| Jan 9, 2014 | K123986 | ACTIM PROM Alere Scarborough, Inc. | OAM |
| Jul 26, 2012 | K121905 | ALERE PBP2A TEST Alere Scarborough, Inc. | MYI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||