FDA.reportPublic FDA data

510(k) K030705

Device
CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL
Applicant
CLINIQA CORPORATION
510(k) number
K030705
Product code
JJY  
Decision
Substantially Equivalent (SESE)
Decision date
2003-03-26
Date received
2003-03-06
Regulation
862.1660
Classification name
Multi-analyte Controls, All Kinds (assayed)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CAROL RUGGIERO
Address
1432 S. Mission Rd. Fallbrook CA US 92028 92028

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JJY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162530Multichem IA PlusTechno-Path Manufacturing2017-03-31
K163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.2017-03-10
K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad Laboratories2017-01-10
K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.2016-01-28
K150300Liquichek Cardiac Markers Plus Control LTBio-Rad Laboratories2015-12-11
K142964VALIDATE Anemia Calibration Verification/ Linearity Test KitMaine Standards Company, LLC2015-04-30
K143379Liquichek Maternal Serum II ControlBio-Rad Laboratories2015-03-13
K143573Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.2015-01-16
K140971LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.Randox Laboratories Limited2014-12-08
K142978Audit MicroControls Linearity LQ Special DiabetesAalto Scientific, Ltd.2014-11-20
K133676ABX PENTRA MICRO ALB CONTROL L/HHORIBA ABX SAS2014-07-11
K141073LIQUICHEK TUMOR MARKER CONTROLBio-Rad Laboratories2014-06-23
K140522RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROLRandox Laboratories Limited2014-05-22
K140916LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAKBio-Rad Laboratories2014-05-06
K140764LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAKBio-Rad Laboratories2014-04-25

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases