SeptiCyte RAPID— 510(k) K203748

Substantially Equivalent

Immunexpress, Inc.

FDA 510(k) clearance K203748 for SeptiCyte RAPID, Substantially Equivalent on 2021-11-29. Applicant: Immunexpress, Inc..

Clearance details

Applicant: Immunexpress, Inc.
Product code: Code PRE
Advisory panel: Microbiology
Date received: 2020-12-23
Decision date: 2021-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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