QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)— 510(k) K896271

Name: FDA 510(k) clearance K896271
Creator: U.S. Food and Drug Administration
Published: 1989-11-08

Substantially Equivalent

Biokit USA, Inc.

FDA 510(k) clearance K896271 for QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL), Substantially Equivalent on 1989-11-08. Applicant: Biokit USA, Inc.. Device class: 2.

Clearance details

Applicant: Biokit USA, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1989-10-30
Decision date: 1989-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

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