510(k) K113349— HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO

Substantially Equivalent

The Binding Site Group , Ltd.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code DAE
Advisory panel: Immunology
Date received: 2011-11-14
Decision date: 2012-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

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