FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY— 510(k) K860027

Substantially Equivalent

Alerchek, Inc.

FDA 510(k) clearance K860027 for FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY, Substantially Equivalent on 1986-04-22. Applicant: Alerchek, Inc..

Clearance details

Applicant
Alerchek, Inc.
Product code
Code DHB
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Portland, ME, US
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