Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Abbott Molecular, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
256 daysmedian FDA review time
582 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252102 | Alinity m HCV | Abbott Molecular, Inc. | 2025-09-25 | 84 | 0 |
| K243489 | Alinity m EBV (09N43-095) | Abbott Molecular, Inc. | 2025-07-28 | 258 | 0 |
| K243485 | Alinity m CMV | Abbott Molecular, Inc. | 2025-07-01 | 235 | 0 |
| K241921 | Alinity m BKV | Abbott Molecular, Inc. | 2025-03-24 | 266 | 0 |
| K241573 | Alinity m Resp-4-Plex | Abbott Molecular, Inc. | 2025-02-14 | 256 | 0 |
| K233349 | Alinity m HSV 1 & 2 / VZV | Abbott Molecular, Inc. | 2024-05-03 | 217 | 0 |
| K222379 | Alinity m STI Assay | Abbott Molecular, Inc. | 2023-03-03 | 210 | 1 |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CT | Abbott Molecular, Inc. | 2022-07-15 | 317 | 0 |
| K202977 | Alinity m STI Assay | Abbott Molecular, Inc. | 2022-04-29 | 576 | 0 |
| K140354 | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TI | Abbott Molecular, Inc. | 2014-05-09 | 86 | 0 |
| K131508 | VYSIS D7S486/CEP 7 FISH PROBE KIT | Abbott Molecular, Inc. | 2013-09-13 | 112 | 0 |
| DEN130010 | VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) | Abbott Molecular, Inc. | 2013-07-29 | 111 | 0 |
| K091960 | VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5 | Abbott Molecular, Inc. | 2011-08-29 | 789 | 0 |
| K100015 | VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM | Abbott Molecular, Inc. | 2011-08-09 | 582 | 0 |
| K092704 | ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLL | Abbott Molecular, Inc. | 2010-05-28 | 267 | 1 |
| K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES) | Abbott Molecular, Inc. | 2010-05-28 | 267 | 7 |
| K080739 | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLE | Abbott Molecular, Inc. | 2008-07-10 | 115 | 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