FHT (FECAL HEME TEST)— 510(k) K905782

Substantially Equivalent

Aerscher, Inc.

FDA 510(k) clearance K905782 for FHT (FECAL HEME TEST), Substantially Equivalent on 1991-05-06. Applicant: Aerscher, Inc.. Device class: 2.

Clearance details

Applicant: Aerscher, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1990-12-21
Decision date: 1991-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chestertown, MD, US

Download summary PDF View on FDA.gov ↗

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