510(k) K214068

Device
Quantia IgE
Applicant
Biokit, S.A.
510(k) number
K214068
Product code
DGC
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-21
Date received
2021-12-27
Regulation
866.5510
Classification name
Ige, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Angels Roma
Address
Av. Can Montcau 7 Lliçà D´Amunt ES 08186 08186

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K992528BIOCHECK IGE ELISA, MODEL BC-1035Biocheck, Inc.1999-09-21
K991316TOUCH TEAR IGE MICROASSAY KITTouch Scientific, Inc.1999-08-09