VISION -FORMERLY PDA- ALKALINE PHOSPHATASE— 510(k) K850110

Name: FDA 510(k) clearance K850110
Creator: U.S. Food and Drug Administration
Published: 1985-01-29

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K850110 for VISION -FORMERLY PDA- ALKALINE PHOSPHATASE, Substantially Equivalent on 1985-01-29. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1985-01-14
Decision date: 1985-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, 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.