PROLACTIN RIABEAD II DIAGNOSTIC KIT— 510(k) K863240

Name: FDA 510(k) clearance K863240
Creator: U.S. Food and Drug Administration
Published: 1986-09-29

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K863240 for PROLACTIN RIABEAD II DIAGNOSTIC KIT, Substantially Equivalent on 1986-09-29. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1986-08-22
Decision date: 1986-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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