FOB ONE STEP RAPID TEST— 510(k) K110309

Substantially Equivalent

Orient Gene Biotech

FDA 510(k) clearance K110309 for FOB ONE STEP RAPID TEST, Substantially Equivalent on 2011-09-14. Applicant: Orient Gene Biotech.

Clearance details

Applicant: Orient Gene Biotech
Product code: Code KHE
Advisory panel: Hematology
Date received: 2011-02-02
Decision date: 2011-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

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