510(k) K163554— hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

Substantially Equivalent

Immunostics Inc.,

Clearance details

Applicant: Immunostics Inc.,
Product code: Code KHE
Advisory panel: Hematology
Date received: 2016-12-19
Decision date: 2017-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Ocean, NJ, US

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