Platelia Aspergillus Eia Model 62793

FDA 510(k) K093678 · Bio-Rad

Substantially Equivalent

510(k) numberK093678

Submission

Device name
Platelia Aspergillus Eia Model 62793
Applicant
Bio-Rad
Redmond, WA, US
Received
November 27, 2009
Decision date
January 13, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NOM – Antigen, Galactomannan, Aspergillus Spp.
Device class
Class I (low risk)
Regulation
21 CFR 866.3040
Specialty
Microbiology

The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum. It is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.

Other 510(k)s with product code NOM

510(k)DeviceApplicantDecision
K243496MycoMEIA Aspergillus AssayNOM · Traditional Pearl Diagnostics, Inc.08/01/2025SE
K060641Platelia Aspergillus Eia, Model 62793NOM · Traditional Bio-Rad06/02/2006SE
K023857Platelia Aspergillus Eia, Models 62793 and 62794NOM · Traditional Bio-Rad05/16/2003SE

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Questions and answers

When was Platelia Aspergillus Eia Model 62793 cleared by the FDA?

Platelia Aspergillus Eia Model 62793 (K093678) received a 510(k) decision of Substantially Equivalent on January 13, 2011, 412 days after the submission was received.

What is the product code of K093678?

The FDA product code is NOM – Antigen, Galactomannan, Aspergillus Spp., a Class I (low risk) device regulated under 21 CFR 866.3040.