Cleared Traditional

K760460 - SCHAEDLER SELECTIVE AGAR-KV (FDA 510(k) Clearance)

Sep 1976
Decision
17d
Days
Class 1
Risk

K760460 is an FDA 510(k) clearance for the SCHAEDLER SELECTIVE AGAR-KV. This device is classified as a Culture Media, Selective And Non-differential (Class I - General Controls, product code JSJ).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on September 3, 1976, 17 days after receiving the submission on August 17, 1976.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K760460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1976
Decision Date September 03, 1976
Days to Decision 17 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSJ — Culture Media, Selective And Non-differential
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2360