Cleared Traditional

K803026 - PEPTONE YEAST EXTRACT GLUCOSE BROTH (FDA 510(k) Clearance)

Dec 1980
Decision
26d
Days
Class 1
Risk

K803026 is an FDA 510(k) clearance for the PEPTONE YEAST EXTRACT GLUCOSE BROTH. This device is classified as a Culture Media, General Nutrient Broth (Class I - General Controls, product code JSC).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 22, 1980, 26 days after receiving the submission on November 26, 1980.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2350.

Submission Details

510(k) Number K803026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1980
Decision Date December 22, 1980
Days to Decision 26 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSC — Culture Media, General Nutrient Broth
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2350