I-CHROMA IFOB WITH I-CHROMA READER— 510(k) K132167

Substantially Equivalent

Boditech Med, Inc.

FDA 510(k) clearance K132167 for I-CHROMA IFOB WITH I-CHROMA READER, Substantially Equivalent on 2014-05-02. Applicant: Boditech Med, Inc..

Clearance details

Applicant: Boditech Med, Inc.
Product code: Code OOX
Advisory panel: Hematology
Date received: 2013-07-12
Decision date: 2014-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chuncheon-Si, Gang-Won-Do, KR

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