Company ยท US
Cliniqa Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2013. Name variants (Inc, Corp, punctuation) are merged.
36510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 22 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 8 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 |
| GGN | Plasma, Coagulation Control | 1 |
| JIT | Calibrator, Secondary | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 31, 2013 | K120900 | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 Cliniqa Corporation | GGN |
| May 18, 2012 | K121237 | BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE Cliniqa Corporation | JJX |
| Apr 21, 2009 | K083554 | CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 Cliniqa Corporation | JJY |
| Jan 16, 2009 | K081908 | CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 Cliniqa Corporation | JJW |
| Sep 17, 2008 | K082107 | CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 Cliniqa Corporation | JJY |
| Jun 2, 2008 | K080973 | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC Cliniqa Corporation | JJY |
| May 4, 2007 | K070741 | CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 Cliniqa Corporation | JJY |
| Oct 23, 2006 | K062916 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 Cliniqa Corporation | JJY |
| May 25, 2006 | K061182 | CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB Cliniqa Corporation | JJY |
| Mar 21, 2006 | K060322 | CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED Cliniqa Corporation | JIT |
| Nov 18, 2005 | K052679 | CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E Cliniqa Corporation | JJX |
| Aug 16, 2004 | K041898 | CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM Cliniqa Corporation | JJX |
| May 17, 2004 | K040927 | LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS Cliniqa Corporation | JJX |
| Mar 29, 2004 | K040535 | LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS Cliniqa Corporation | JJY |
| Mar 5, 2004 | K040455 | LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS Cliniqa Corporation | JJX |
| Feb 23, 2004 | K040091 | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS Cliniqa Corporation | JJY |
| Jan 30, 2004 | K033910 | OLYMPUS URINE CALIBRATOR Cliniqa Corporation | JIX |
| Oct 21, 2003 | K032074 | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS Cliniqa Corporation | JJY |
| Oct 10, 2003 | K033162 | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS Cliniqa Corporation | JJY |
| Aug 25, 2003 | K031921 | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS Cliniqa Corporation | JJY |
| Aug 6, 2003 | K031577 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS Cliniqa Corporation | JJY |
| Jul 23, 2003 | K031575 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS Cliniqa Corporation | JJY |
| Mar 26, 2003 | K030705 | CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL Cliniqa Corporation | JJY |
| Mar 21, 2003 | K030768 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL Cliniqa Corporation | JJT |
| Mar 13, 2003 | K030566 | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS Cliniqa Corporation | JJY |
| Jan 28, 2003 | K030150 | LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS Cliniqa Corporation | JJY |
| Jan 21, 2003 | K030074 | LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS Cliniqa Corporation | JIX |
| Dec 6, 2002 | K023661 | LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS Cliniqa Corporation | JJY |
| Oct 17, 2002 | K023250 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE Cliniqa Corporation | JJY |
| Oct 2, 2002 | K022936 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE Cliniqa Corporation | JJY |
| Oct 2, 2002 | K022885 | LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE Cliniqa Corporation | JJY |
| Oct 2, 2002 | K022867 | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE Cliniqa Corporation | JJY |
| Sep 17, 2002 | K022758 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER Cliniqa Corporation | JJX |
| Aug 27, 2002 | K022491 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS Cliniqa Corporation | JJX |
| Aug 1, 2002 | K022232 | CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 Cliniqa Corporation | JJX |
| Nov 20, 2001 | K013332 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE Cliniqa Corporation | JJY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||