I.M.N. LATEX— 510(k) K874678

Substantially Equivalent

Biokit USA, Inc.

FDA 510(k) clearance K874678 for I.M.N. LATEX, Substantially Equivalent on 1987-12-14. Applicant: Biokit USA, Inc.. Device class: 2.

Clearance details

Applicant
Biokit USA, Inc.
Product code
Code KTN
Device class
Class 2
Regulation
21 CFR 866.5640
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Barcelona, Spain, US
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