Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cliniqa Corporation — Predicate Candidate Screening

36 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

35 daysmedian FDA review time

106 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K120900	I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2	Cliniqa Corporation	2013-05-31	431	0
K121237	BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG C	Cliniqa Corporation	2012-05-18	24	0
K083554	CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3	Cliniqa Corporation	2009-04-21	141	0
K081908	CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2	Cliniqa Corporation	2009-01-16	197	0
K082107	CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2	Cliniqa Corporation	2008-09-17	54	0
K080973	CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,	Cliniqa Corporation	2008-06-02	59	0
K070741	CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CO	Cliniqa Corporation	2007-05-04	49	0
K062916	CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3	Cliniqa Corporation	2006-10-23	25	0
K061182	CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID C	Cliniqa Corporation	2006-05-25	28	0
K060322	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, C	Cliniqa Corporation	2006-03-21	40	2
K052679	CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQ	Cliniqa Corporation	2005-11-18	51	0
K041898	CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICA	Cliniqa Corporation	2004-08-16	33	0
K040927	LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLY	Cliniqa Corporation	2004-05-17	38	0
K040535	LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN	Cliniqa Corporation	2004-03-29	27	0
K040455	LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLY	Cliniqa Corporation	2004-03-05	11	0
K040091	LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMP	Cliniqa Corporation	2004-02-23	38	0
K033910	OLYMPUS URINE CALIBRATOR	Cliniqa Corporation	2004-01-30	44	0
K032074	LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKM	Cliniqa Corporation	2003-10-21	106	0
K033162	LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMP	Cliniqa Corporation	2003-10-10	10	0
K031921	LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BEC	Cliniqa Corporation	2003-08-25	63	0
K031577	LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKM	Cliniqa Corporation	2003-08-06	78	0
K031575	LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMP	Cliniqa Corporation	2003-07-23	64	0
K030705	CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEV	Cliniqa Corporation	2003-03-26	20	0
K030768	CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TR	Cliniqa Corporation	2003-03-21	10	1
K030566	LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE O	Cliniqa Corporation	2003-03-13	17	0
K030150	LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKM	Cliniqa Corporation	2003-01-28	13	0
K030074	LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECK	Cliniqa Corporation	2003-01-21	13	0
K023661	LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN	Cliniqa Corporation	2002-12-06	36	0
K023250	LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE B	Cliniqa Corporation	2002-10-17	17	0
K022867	LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE	Cliniqa Corporation	2002-10-02	35	0
K022936	LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN C	Cliniqa Corporation	2002-10-02	28	0
K022885	LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKM	Cliniqa Corporation	2002-10-02	33	0
K022758	LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE	Cliniqa Corporation	2002-09-17	28	0
K022491	LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS A	Cliniqa Corporation	2002-08-27	29	0
K022232	CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3	Cliniqa Corporation	2002-08-01	22	0
K013332	LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKM	Cliniqa Corporation	2001-11-20	42	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda