ABBOTT ARCHITECT B12— 510(k) K984108

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K984108 for ABBOTT ARCHITECT B12, Substantially Equivalent on 1999-02-03. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant
Abbott Laboratories
Product code
Code LIG
Device class
Class 2
Regulation
21 CFR 862.1810
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Abbott Park, IL, US
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