# Abbott Point of Care, Inc.

- Location (FDA's records): Princton, NJ
- FDA decisions: 22 (2011–2026): 22 510(k) clearances
- Names in FDA's records: Abbott Point of Care, Inc. (21); Abbott Point of Care (1)
- Product codes: CGA (6), CHL (4), JGS (3), MMI (2), JFP (2), JPI (1), JFL (1), DHA (1), QAT (1), CGL (1)
- 510(k) review time since 2016: median 267 days, against 258 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 28 (13 its own); citations of its devices by later devices: 15 (13 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Beckman Coulter, Inc.: 3 (https://510kreport.com/company/beckman-coulter)
- Abbott Laboratories: 3 (https://510kreport.com/company/abbott-laboratories)
- Siemens Healthcare Diagnostics, Inc.: 2 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Epocal, Inc.: 2 (https://510kreport.com/company/epocal)
- Phc Corporation: 1 (https://510kreport.com/company/phc)
- I-Stat Corp.: 1 (https://510kreport.com/company/i-stat)
- Cliniqa Corporation: 1 (https://510kreport.com/company/cliniqa)
- Radiometer Medical Aps: 1 (https://510kreport.com/company/radiometer-medical)

## Firms that cite its devices most
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Radiometer Medicals Aps: 1 (https://510kreport.com/company/radiometer-medicals)

## Its most-cited devices
- K103195: I-Stat 1 Wireless Analyzer (2011), cited by 3
- K183688: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), cited by 2
- K191360: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), cited by 2
- K210958: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2021), cited by 2
- K223857: i-STAT G3+ cartridge with the i-STAT 1 System (2023), cited by 1
- K183678: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), cited by 1

## Recent decisions
- K261039: i-STAT Crea cartridge with the i-STAT 1 System (Jun 26, 2026)
- K253051: i-STAT hs-TnI cartridge with the i-STAT Alinity System (Jun 11, 2026)
- K244014: i-STAT CG4+ cartridge with the i-STAT 1 System (May 2, 2025)
- K240984: i-STAT hs-TnI cartridge with the i-STAT 1 System (Jan 3, 2025)
- K234143: i-STAT TBI Cartridge with the i-STAT Alinity System (Mar 27, 2024)
- K230285: i-STAT CG8+ cartridge with the i-STAT 1 System (Oct 27, 2023)
- K230275: i-STAT CG8+ cartridge with the i-STAT 1 System (Oct 27, 2023)
- K230300: i-STAT CG8+ cartridge with the i-STAT 1 System (Oct 27, 2023)

Source page: https://510kreport.com/company/abbott-point-of-care