TOXOGEN— 510(k) K913467

Substantially Equivalent

Biokit USA, Inc.

FDA 510(k) clearance K913467 for TOXOGEN, Substantially Equivalent on 1993-01-11. Applicant: Biokit USA, Inc.. Device class: 2.

Clearance details

Applicant
Biokit USA, Inc.
Product code
Code LLA
Device class
Class 2
Regulation
21 CFR 866.3780
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Barcelona, ES
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