Optilite IgA Kit— 510(k) K191985

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K191985 for Optilite IgA Kit, Substantially Equivalent on 2019-08-19. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2019-07-25
Decision date: 2019-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Edgbaston, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.