HEMAPROMPT— 510(k) K981661

Substantially Equivalent

Aerscher Diagnostics

FDA 510(k) clearance K981661 for HEMAPROMPT, Substantially Equivalent on 1998-09-15. Applicant: Aerscher Diagnostics.

Clearance details

Applicant: Aerscher Diagnostics
Product code: Code KHE
Advisory panel: Hematology
Date received: 1998-05-06
Decision date: 1998-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chestertown, MD, US

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