Cleared Traditional

K920565 - BBL STREP GROUPING KIT (FDA 510(k) Clearance)

K920565 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device

Mar 1992

Decision

45d

Days

Class 1

Risk

K920565 is an FDA 510(k) clearance for the BBL STREP GROUPING KIT. This device is classified as a Antisera, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTZ).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Cockeysville, US). The FDA issued a Cleared decision on March 23, 1992, 45 days after receiving the submission on February 7, 1992.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K920565 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 07, 1992
Decision Date	March 23, 1992
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	GTZ — Antisera, All Groups, Streptococcus Spp.
Device Class	Class I - General Controls
CFR Regulation	21 CFR 866.3740