Cleared Traditional

K863573 - BIRD SEED AGAR (FDA 510(k) Clearance)

Sep 1986
Decision
18d
Days
Class 1
Risk

K863573 is an FDA 510(k) clearance for the BIRD SEED AGAR. This device is classified as a Culture Media, Non-selective And Differential (Class I - General Controls, product code JSH).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 30, 1986, 18 days after receiving the submission on September 12, 1986.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number K863573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1986
Decision Date September 30, 1986
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSH — Culture Media, Non-selective And Differential
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2320