RUBASCAN LATEX CARD TEST— 510(k) K832228

Name: FDA 510(k) clearance K832228
Creator: U.S. Food and Drug Administration
Published: 1983-09-29

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K832228 for RUBASCAN LATEX CARD TEST, Substantially Equivalent on 1983-09-29. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code GOK
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1983-07-11
Decision date: 1983-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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