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510(k) K984433

Device
QUANTECH CK-MB ASSAY
Applicant
QUANTECH LTD.
510(k) number
K984433
Product code
MYT  
Decision
Substantially Equivalent (SESE)
Decision date
1999-11-01
Date received
1998-12-14
Regulation
862.1215
Classification name
Biosensor, Immunoassay, Cpk Or Isoenzymes
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBIN J HELLEN
Address
9418 Lasaine Ave. Northridge CA US 91325 91325

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MYT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K051433I-STAT CREATINE KINASE MB (CK-MB)I-Stat Corporation2005-12-15
K033155BIOCENTREX CARDIAC PANELBiocentrex2004-01-12

Legacy Summary#

summary

FDA Review#

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