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510(k) K000733

Device
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
Applicant
INOVA DIAGNOSTICS, INC.
510(k) number
K000733
Product code
NBT  
Decision
Substantially Equivalent (SESE)
Decision date
2001-05-21
Date received
2000-03-06
Regulation
866.5785
Classification name
Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BRYS C MYERS
Address
10180 Scripps Ranch Blvd. San Diego CA US 92131 92131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NBT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K071711ASCA-CHEKTechlab Inc., Corporate Research Center2007-11-07
K051927TECHLAB ASCA-CHEKTechlab, Inc.2006-04-06
K051492AESKULISA ASCA AAesku, Inc.2005-11-14
K042579BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KITThe Binding Site2005-07-28
K032850IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)Immco Diagnostics, Inc.2004-03-18
K032860IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)Immco Diagnostics, Inc.2004-03-18
DEN000007QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISAInova Diagnostics, Inc.2000-08-16

Legacy Summary#

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FDA Review#

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