# Cliniqa Corporation

- Location (FDA's records): Fallbrook, CA
- FDA decisions: 36 (2001–2013): 36 510(k) clearances
- Product codes: JJY (22), JJX (8), JIX (2), JJT (1), JJW (1), GGN (1), JIT (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Maine Standards Co.: 2 (https://510kreport.com/company/maine-standards)
- Aalto Scientific, Ltd.: 1 (https://510kreport.com/company/aalto-scientific)
- Axis-Shield Poc AS: 1 (https://510kreport.com/company/axis-shield-poc)
- Cone Bioproducts: 1 (https://510kreport.com/company/cone-bioproducts)
- Abbott Point of Care, Inc.: 1 (https://510kreport.com/company/abbott-point-of-care)

## Its most-cited devices
- K061182: Cliniqa Liquid QC Lipid Control Levels 1 & 2;Linical Lipid Calibration Verifiers Levels a-E for Olympus AU Systems;Qalib (2006), cited by 1
- K040535: Linical Enzyme Calibration Verifiers Levels a-E for Beckman Coulter Synchron Systems (2004), cited by 1
- K022232: Cliniqa Liquid-QC HCG Control Level 1, 2, and 3 (2002), cited by 1
- K121237: Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG Calibration Verification Controls LE (2012), cited by 1
- K031575: Linical Protein 2 Calibration Verifiers Levels a-E for Olympus AU Analyzers (2003), cited by 1
- K023661: Linical RF-CRP Calibration Verifiers Levels a-E for Beckman Coulter Synchron CX Systems (2002), cited by 1

## Recent decisions
- K120900: I-Stat PT Control Leviel 1 I-Stat PT Control Level 2 (May 31, 2013)
- K121237: Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG Calibration Verification Controls LE (May 18, 2012)
- K083554: Cliniqa Liquidqc Immunoassay Control Level 1, 2 & 3 (Apr 21, 2009)
- K081908: Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2 (Jan 16, 2009)
- K082107: Cliniqa Liquid QC Urine Chemistry Controls, Levels 1 and 2 (Sep 17, 2008)
- K080973: Cliniqa Liquid QC  Complete Cardiac Marker Control, Levels 1,2, and 3; Cardiac Marker Control-Low, and Linical Cardiac (Jun 2, 2008)
- K070741: Cliniqa Liquid QC Unassayed and Assayed General Chemistry Control Levels 1, 2, & 3 (May 4, 2007)
- K062916: Cliniqa Liquid QC Cardiac Marker Control SP, Levels 1,2, &3 (Oct 23, 2006)

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