VISUWELL SYPHILIS ANTIBODY— 510(k) K932453

Name: FDA 510(k) clearance K932453
Creator: U.S. Food and Drug Administration
Published: 1995-07-11

Substantially Equivalent

Biomira Diagnostics, Inc.

FDA 510(k) clearance K932453 for VISUWELL SYPHILIS ANTIBODY, Substantially Equivalent on 1995-07-11. Applicant: Biomira Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Biomira Diagnostics, Inc.
Product code: Code LIP
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1993-05-20
Decision date: 1995-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rexdale, Ontario, CA

Download summary PDF View on FDA.gov ↗

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