Cleared Traditional

K952721 - RUBASCAN CARD TEST (FDA 510(k) Clearance)

K952721 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Dec 1996
Decision
554d
Days
Class 2
Risk

K952721 is an FDA 510(k) clearance for the RUBASCAN CARD TEST. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II - Special Controls, product code LFX).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Columbus, US). The FDA issued a Cleared decision on December 20, 1996, 554 days after receiving the submission on June 15, 1995.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K952721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1995
Decision Date December 20, 1996
Days to Decision 554 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II - Special Controls
CFR Regulation 21 CFR 866.3510