Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alere Scarborough, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
379 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| DEN180014 | WOUNDCHEK Bacterial Status | Alere Scarborough, Inc. | 2019-12-02 | 619 | 0 |
| K190204 | ID NOW Influenza A & B 2 | Alere Scarborough, Inc. | 2019-03-18 | 42 | 0 |
| K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader | Alere Scarborough, Inc. | 2018-08-08 | 28 | 0 |
| K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Con | Alere Scarborough, Inc. | 2018-05-02 | 155 | 0 |
| K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere | Alere Scarborough, Inc. | 2018-01-26 | 31 | 0 |
| K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere B | Alere Scarborough, Inc. | 2017-12-13 | 30 | 0 |
| K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influ | Alere Scarborough, Inc. | 2017-09-29 | 105 | 1 |
| K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere B | Alere Scarborough, Inc. | 2017-04-10 | 200 | 0 |
| K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swa | Alere Scarborough, Inc. | 2016-12-21 | 30 | 0 |
| K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Ki | Alere Scarborough, Inc. | 2016-08-18 | 92 | 2 |
| K161364 | BinaxNOW G6PD Test | Alere Scarborough, Inc. | 2016-06-17 | 31 | 0 |
| K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influen | Alere Scarborough, Inc. | 2015-07-28 | 57 | 0 |
| K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A | Alere Scarborough, Inc. | 2015-07-16 | 23 | 0 |
| K141757 | ALERE I STREP A | Alere Scarborough, Inc. | 2015-03-31 | 274 | 0 |
| K133851 | ALERE PBP2A SA/CONS CULTURE COLONY TEST | Alere Scarborough, Inc. | 2014-09-03 | 258 | 0 |
| K123986 | ACTIM PROM | Alere Scarborough, Inc. | 2014-01-09 | 379 | 1 |
| K121905 | ALERE PBP2A TEST | Alere Scarborough, Inc. | 2012-07-26 | 27 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda