TRUQUANT BR RIA— 510(k) K965141

Substantially Equivalent

Biomira USA, Inc.

FDA 510(k) clearance K965141 for TRUQUANT BR RIA, Substantially Equivalent on 1997-10-31. Applicant: Biomira USA, Inc.. Device class: 2.

Clearance details

Applicant: Biomira USA, Inc.
Product code: Code MOI
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1996-12-23
Decision date: 1997-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranberry, NJ, US

Download summary PDF View on FDA.gov ↗

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