TDX AMYLASE— 510(k) K853978

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K853978 for TDX AMYLASE, Substantially Equivalent on 1985-10-15. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CIX
Advisory panel: Clinical Chemistry
Date received: 1985-09-26
Decision date: 1985-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

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