Cleared Traditional

K832228 - RUBASCAN LATEX CARD TEST (FDA 510(k) Clearance)

K832228 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device

Sep 1983

Decision

80d

Days

Class 2

Risk

K832228 is an FDA 510(k) clearance for the RUBASCAN LATEX CARD TEST. This device is classified as a Antisera, Hai (including Hai Control), Rubella (Class II - Special Controls, product code GOK).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on September 29, 1983, 80 days after receiving the submission on July 11, 1983.

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

Submission Details

510(k) Number	K832228 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 11, 1983
Decision Date	September 29, 1983
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—