DeviceClearance

Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator— 510(k) K150412

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K150412 for Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator, Substantially Equivalent on 2015-08-28. Applicant: The Binding Site Group , Ltd..

Clearance details

Applicant
The Binding Site Group , Ltd.
Product code
Code DAE
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Birmingham, GB
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