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510(k) K033155

Device
BIOCENTREX CARDIAC PANEL
Applicant
BIOCENTREX
510(k) number
K033155
Product code
MYT  
Decision
Substantially Equivalent (SESE)
Decision date
2004-01-12
Date received
2003-09-30
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
THOMAS H GROVE
Address
6100 Bristol Pkwy. Culver City CA US 90230 90230

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
K984433QUANTECH CK-MB ASSAYQuantech , Ltd.1999-11-01

Legacy Summary#

summary

FDA Review#

Decision Summary