UALB— 510(k) K983774

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K983774 for UALB, Substantially Equivalent on 1999-01-28. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JIR
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1998-10-26
Decision date: 1999-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, 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.