Alere Scarborough, Inc.
Scarborough, ME, US
Alere Scarborough, Inc. appears in FDA device records in Scarborough, ME. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Alere Scarborough, Inc. between 2012 and 2019. The busiest year on record is 2015, with 3. The most recent is 2019, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 3 |
| 2017 | 3 |
| 2018 | 3 |
| 2019 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| DEN180014 | WOUNDCHEK Bacterial Status | QFA | Unknown | |
| K190204 | ID NOW Influenza A & B 2 | OZE | Substantially Equivalent | |
| K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader | PSZ | Substantially Equivalent | |
| K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit | PGX | Substantially Equivalent | |
| K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | OCC | Substantially Equivalent | |
| K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | PSZ | Substantially Equivalent | |
| K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | OCC | Substantially Equivalent | |
| K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | PSZ | Substantially Equivalent | |
| K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument | OCC | Substantially Equivalent | |
| K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit | OCC | Substantially Equivalent | |
| K161364 | BinaxNOW G6PD Test | JBF | Substantially Equivalent | |
| K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | OCC | Substantially Equivalent | |
| K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A | OOI | Substantially Equivalent | |
| K141757 | ALERE I STREP A | PGX | Substantially Equivalent | |
| K133851 | ALERE PBP2A SA/CONS CULTURE COLONY TEST | MYI | Substantially Equivalent | |
| K123986 | ACTIM PROM | OAM | Substantially Equivalent | |
| K121905 | ALERE PBP2A TEST | MYI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- QFAAssay For Detection Of Proteases In Chronic Wounds
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
- PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- OAMImmunoassay, Insulin-Like Growth Factor Binding Protein-1
- OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay
- OOIReal Time Nucleic Acid Amplification System
- OCCRespiratory Virus Panel Nucleic Acid Assay System
- MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain