DYNA-LYTE 2000— 510(k) K842786

Substantially Equivalent

Abbott Diagnostics

FDA 510(k) clearance K842786 for DYNA-LYTE 2000, Substantially Equivalent on 1984-09-14. Applicant: Abbott Diagnostics. Device class: 2.

Clearance details

Applicant: Abbott Diagnostics
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1984-05-22
Decision date: 1984-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.