510(k) Report

FDA applicant

Cliniqa Corporation

Fallbrook, CA36 decisions2001–20133 recalls

FDA records 36 decisions for Cliniqa Corporation (Fallbrook, CA) from 2001 to 2013: 36 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JJX (Single (Specified) Analyte Controls (Assayed…). Its devices cite 1 predicate, 1 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Cliniqa Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12008: 22009: 22012: 12013: 1
2007high 2 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2012

2007: 12008: 12012: 1
2007high 1 (2007) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Cliniqa Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JJYMulti-Analyte Controls, All Kinds (Assayed)22decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)8decisions
  • JIXCalibrator, Multi-Analyte Mixture2decisions
  • JJTEnzyme Controls (Assayed And Unassayed)1decision
  • JJWUrinalysis Controls (Assayed And Unassayed)1decision
  • GGNPlasma, Coagulation Control1decision

Also: JIT (1).

Who builds on its devices?

Later devices cite its devices 7 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K061182Cliniqa Liquid QC Lipid Control Levels 1 & 2;Linical Lipid Calibration Verifiers Levels a-E for Olympus AU…Cliniqa Corporation · 20061cites it
  • K040535Linical Enzyme Calibration Verifiers Levels a-E for Beckman Coulter Synchron SystemsCliniqa Corporation · 20041cites it
  • K022232Cliniqa Liquid-QC HCG Control Level 1, 2, and 3Cliniqa Corporation · 20021cites it
  • K121237Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG Calibration Verification…Cliniqa Corporation · 20121cites it
  • K031575Linical Protein 2 Calibration Verifiers Levels a-E for Olympus AU AnalyzersCliniqa Corporation · 20031cites it
  • K023661Linical RF-CRP Calibration Verifiers Levels a-E for Beckman Coulter Synchron CX SystemsCliniqa Corporation · 20021cites it

What has FDA decided for it lately?

  • K120900I-Stat PT Control Leviel 1 I-Stat PT Control Level 2Cliniqa Corporation · 2013
  • K121237Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG Calibration Verification…Cliniqa Corporation · 2012
  • K083554Cliniqa Liquidqc Immunoassay Control Level 1, 2 & 3Cliniqa Corporation · 2009
  • K081908Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2Cliniqa Corporation · 2009
  • K082107Cliniqa Liquid QC Urine Chemistry Controls, Levels 1 and 2Cliniqa Corporation · 2008
  • K080973Cliniqa Liquid QC Complete Cardiac Marker Control, Levels 1,2, and 3; Cardiac Marker Control-Low, and…Cliniqa Corporation · 2008
  • K070741Cliniqa Liquid QC Unassayed and Assayed General Chemistry Control Levels 1, 2, & 3Cliniqa Corporation · 2007
  • K062916Cliniqa Liquid QC Cardiac Marker Control SP, Levels 1,2, &3Cliniqa Corporation · 2006

All 36 as Cliniqa Corporation →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K030768Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot…Jul 19, 2012Class III
  • K050369da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System…Jun 1, 2008
  • K050369Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5…Mar 30, 2007