510(k) clearances

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls

Biokit, S.A. · Microbiology

K243575Substantially EquivalentTraditionalMYF
Open FDA's page for this record
Third party flag
N
City
Lliçà D’Amunt, Barcelona
Advisory committee description
Microbiology
Address 1
Av. Can Montcau, 7
Statement or summary
Summary
Product code
MYF
Zip code
08186
Applicant
Biokit, S.A.
Decision date
2025-02-12
Decision code
SESE
Country code
ES
Device name
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
Advisory committee
MI
Contact
Janna Puig
K number
K243575
Date received
2024-11-19
Review advisory committee
MI
Postal code
08186
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Medical specialty description
Microbiology
Regulation number
866.3305
Device class
2
Registration number
1318354, 2029372, 9610126, 2023365, 3032705, 9610746, 3005333358, 2432235, 2915274, 1641328, 2242436, 2182595, 3008344661
FEI number
1318354, 2023365, 1000306617, 3002701146, 3002806559, 2432235, 3005333358, 2915274, 1641328, 2242436, 2182595, 3008344661, 3002806557
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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.