TDXR 5-HIAA (URINE)— 510(k) K854946

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K854946 for TDXR 5-HIAA (URINE), Substantially Equivalent on 1986-01-17. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CDA
Device class: Class 1
Regulation: 21 CFR 862.1390
Advisory panel: Clinical Chemistry
Date received: 1985-12-10
Decision date: 1986-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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