# Streck

- Location (FDA's records): La Vista, NE
- FDA decisions: 38 (2005–2026): 37 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Streck (33); Streck, Inc. (3); Streck, LLC (2)
- Product codes: JPK (12), KRX (7), PMN (6), GLQ (4), GGL (2), GJR (2), JJW (2), QMA (2), GIM (1)
- 510(k) review time since 2016: median 90 days, against 90 for FDA's reviews in the same codes and years (3 of 9 faster)
- Predicates its devices cite: 35 (23 its own); citations of its devices by later devices: 25 (23 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Streck Laboratories, Inc.: 9 (https://510kreport.com/company/streck-laboratories)
- Medical Analysis Systems, Inc.: 1 (https://510kreport.com/company/medical-analysis-systems)
- Sysmex America, Inc.: 1 (https://510kreport.com/company/sysmex-america)
- Maine Molecular Quality Controls, Inc.: 1 (https://510kreport.com/company/maine-molecular-quality-controls)

## Firms that cite its devices most
- R&D Systems, Inc.: 1 (https://510kreport.com/company/r-d-systems)
- Caltag Medsystems, Ltd.: 1 (https://510kreport.com/company/caltag-medsystems)

## Its most-cited devices
- K053362: Cell-Chex Auto (2006), cited by 3
- K212576: MDx-Chex for BCID2 (2022), cited by 3
- K083200: X-CAL (2009), cited by 2
- K141964: XN Check (2014), cited by 2
- K051706: IQ Body Fluids Control (2005), cited by 1
- K120747: XN Cal PF (2012), cited by 1

## Recent decisions
- K260041: MDx-Chex for BCP (Mar 27, 2026)
- K254166: MDx-Chex for BCN (Mar 23, 2026)
- K254167: MDx-Chex for BCY (Mar 17, 2026)
- K231776: Cell-Free DNA BCT (Jul 26, 2024)
- K231221: MDx-Chex for BC-GP (Jul 27, 2023)
- K231223: MDx-Chex for BC-GN (Jul 27, 2023)
- K212576: MDx-Chex for BCID2 (Jan 19, 2022)
- DEN200001: Cell-Free DNA BCT (Aug 7, 2020)

Source page: https://510kreport.com/company/streck