Cleared Traditional

K872020 - MUCATE AGAR, SLANTS AND MUCATE BROTH (FDA 510(k) Clearance)

Jun 1987
Decision
7d
Days
Class 1
Risk

K872020 is an FDA 510(k) clearance for the MUCATE AGAR, SLANTS AND MUCATE BROTH. 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 June 2, 1987, 7 days after receiving the submission on May 26, 1987.

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

Submission Details

510(k) Number K872020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1987
Decision Date June 02, 1987
Days to Decision 7 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