510(k) clearances

Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit

The Binding Site, Ltd. · Immunology

K231290Substantially EquivalentTraditionalDFH
Open FDA's page for this record
Third party flag
N
City
Birmingham
Advisory committee description
Immunology
Address 1
8 Calthorpe Rd.
Statement or summary
Summary
Product code
DFH
Zip code
B15 1QT
Applicant
The Binding Site, Ltd.
Decision date
2024-01-24
Decision code
SESE
Country code
GB
Device name
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
Advisory committee
IM
Contact
Jolanta Wolff
K number
K231290
Date received
2023-05-04
Review advisory committee
IM
Postal code
B15 1QT
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Kappa, Antigen, Antiserum, Control
Medical specialty description
Immunology
Regulation number
866.5550
Device class
2
Registration number
3003423869, 3009189893, 9610806, 2050010, 8023024, 9681753, 9614373, 9610099, 1649518, 1618982, 3019906, 2050012, 2032900, 3003961883, 2083566, 3013059683, 3012471076, 3014271897
FEI number
3003423869, 3004445302, 3009189893, 2050010, 3002808340, 1618982, 3001236277, 3001644026, 3002806778, 3019906, 2050012, 6387, 3003961883, 2083566, 3000303338, 3013059683, 3012471076, 3014271897
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.