TDX(R) AMYLASE II— 510(k) K863622

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K863622 for TDX(R) AMYLASE II, Substantially Equivalent on 1986-10-03. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1986-09-16
Decision date: 1986-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

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