SeptiCyte LAB— 510(k) K163260

Substantially Equivalent

Immunexpress, Inc.

FDA 510(k) clearance K163260 for SeptiCyte LAB, Substantially Equivalent on 2017-02-17. Applicant: Immunexpress, Inc..

Clearance details

Applicant: Immunexpress, Inc.
Product code: Code PRE
Advisory panel: Microbiology
Date received: 2016-11-21
Decision date: 2017-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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