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510(k) K860906

Device
STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III
Applicant
AMERICAN DADE
510(k) number
K860906
Product code
JJY  
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-29
Date received
1986-03-10
Regulation
862.1660
Classification name
Multi-analyte Controls, All Kinds (assayed)
Medical specialty
Clinical Chemistry
Review panel
Toxicology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KAREN H DARCY
Address
P.O. Box 25101 Santa Ana CA US 92799 92799

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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