# Abbott Molecular, Inc.

- Location (FDA's records): Des Plaines, IL
- FDA decisions: 33 (1998–2025): 18 510(k) clearances, 1 De Novo grant and 14 original PMA approvals
- Names in FDA's records: Abbott Molecular, Inc. (28); Abbott Molecular (5)
- Product codes: MZP (3), PAB (3), QLX (2), OWD (2), MKT (2), QEP (2), OWE (1), MAQ (1), PNK (1), PFG (1), QOF (1), PDO (1)
- 510(k) review time since 2016: median 246 days, against 252 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 24 (7 its own); citations of its devices by later devices: 10 (7 its own)
- Recalls linked to its devices: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Molecular Systems, Inc.: 4 (https://510kreport.com/company/roche-molecular-systems)
- Becton, Dickinson & CO: 4 (https://510kreport.com/company/becton-dickinson)
- Gen-Probe, Inc.: 4 (https://510kreport.com/company/gen-probe)
- Hologic, Inc.: 3 (https://510kreport.com/company/hologic)
- Agendia BV: 1 (https://510kreport.com/company/agendia)
- Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.): 1 (https://510kreport.com/company/letsgetchecked-formerly-privapath-diagnostics)

## Firms that cite its devices most
- QIAGEN GmbH: 1 (https://510kreport.com/company/qiagen)
- Roche Molecular Systems, Inc.: 1 (https://510kreport.com/company/roche-molecular-systems)
- Life Technologies Corporation: 1 (https://510kreport.com/company/life-technologies)

## Its most-cited devices
- K092705: Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501 (2010), cited by 2
- P190025: Alinity m HCV (2020), cited by 1
- P210022: Alinity m CMV (2022), cited by 1
- K212778: Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) (2022), cited by 1
- DEN130010: Vysis EGR1 Fish Probe Kit - SC (Specimen Characterization) (2013), cited by 1
- K202977: Alinity m STI Assay (2022), cited by 1

## Recent decisions
- K252102: Alinity m HCV (Sep 25, 2025)
- K243489: Alinity m EBV (09N43-095) (Jul 28, 2025)
- K243485: Alinity m CMV (Jul 1, 2025)
- K241921: Alinity m BKV (Mar 24, 2025)
- K241573: Alinity m Resp-4-Plex (Feb 14, 2025)
- K243410: simpli-COLLECT STI Test (Jan 30, 2025)
- K241580: Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) (Dec 6, 2024)
- K233349: Alinity m HSV 1 & 2 / VZV (May 3, 2024)

Source page: https://510kreport.com/company/abbott-molecular