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510(k) K980514

Device
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002
Applicant
MEDICAL ANALYSIS SYSTEMS, INC.
510(k) number
K980514
Product code
JJY  
Decision
Substantially Equivalent (SESE)
Decision date
1998-03-04
Date received
1998-02-10
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
SCOTT D KINGHORN
Address
542 Flynn Rd. Camarillo CA US 93012 93012

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#

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FDA Review#

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