# Hemocue, Inc.

- Location (FDA's records): Potomac, MD
- FDA decisions: 15 (1991–2020): 15 510(k) clearances
- Names in FDA's records: Hemocue, Inc. (9); Hemocue AB (6)
- Product codes: GKR (6), LFR (4), CGA (3), GKL (1), KQO (1)
- Predicates its devices cite: 5 (4 its own); citations of its devices by later devices: 9 (4 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sysmex America, Inc.: 1 (https://510kreport.com/company/sysmex-america)

## Firms that cite its devices most
- Sanguina, Inc.: 2 (https://510kreport.com/company/sanguina)
- Immunostics Inc.,: 2 (https://510kreport.com/company/immunostics)
- Mec Dynamics Corp: 1 (https://510kreport.com/company/mec-dynamics)

## Its most-cited devices
- K032203: Hemocue Hemoglobin 201 + System Article 121704 (2003), cited by 3
- K061047: Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801 (2006), cited by 3
- K041234: Hemocue Hemoglobin 201DM Analyzing System (2004), cited by 1
- K181751: HemoCue Hb 801 System (2019), cited by 1
- K020935: Hemocue Glucose 201 System, Article Number 120706 (2002), cited by 1

## Recent decisions
- K201217: HemoCue Hb 301 System (Aug 4, 2020)
- K181751: HemoCue Hb 801 System (Feb 1, 2019)
- K071652: Hemocue WBC System (Oct 25, 2007)
- K060765: Hemocue Glucose 201 RT Analyzer MDL 120731, Hemocue Glucose 201 RT Microcurettes MDL 110712 (Sep 6, 2006)
- K061047: Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801 (Jun 8, 2006)
- K053253: Hemocue Albumin 201 Analyzing System (Feb 17, 2006)
- K041234: Hemocue Hemoglobin 201DM Analyzing System (Jun 10, 2004)
- K041230: Clinical Laboratory Analyzing System (May 20, 2004)

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