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510(k) K093678

Device
PLATELIA ASPERGILLUS EIA MODEL 62793
Applicant
BIO-RAD
510(k) number
K093678
Product code
NOM  
Decision
Substantially Equivalent (SESE)
Decision date
2011-01-13
Date received
2009-11-27
Regulation
866.3040
Classification name
Antigen, Galactomannan, Aspergillus Spp.
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHRISTOPHER BENTSEN
Address
6565 185th Ave., NE Redmond WA US 98052 98052

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NOM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243496MycoMEIA Aspergillus AssayPearl Diagnostics, Inc.2025-08-01
K060641PLATELIA ASPERGILLUS EIA, MODEL 62793Bio-Rad2006-06-02
K023857PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794Bio-Rad2003-05-16

Legacy Summary#

summary

FDA Review#

Decision Summary