QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)— 510(k) K894486

Name: FDA 510(k) clearance K894486
Creator: U.S. Food and Drug Administration
Published: 1989-10-24

Substantially Equivalent

Biokit USA, Inc.

FDA 510(k) clearance K894486 for QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL), Substantially Equivalent on 1989-10-24. Applicant: Biokit USA, Inc.. Device class: 1.

Clearance details

Applicant: Biokit USA, Inc.
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1989-07-18
Decision date: 1989-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

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