Cleared Traditional

K771936 - MICROBIOLOGICAL CULTURE MEDIUM
(FDA 510(k) Clearance)

Dec 1977
Decision
50d
Days
Class 1
Risk

K771936 is an FDA 510(k) clearance for the MICROBIOLOGICAL CULTURE MEDIUM. This device is classified as a Culture Media, Non-selective And Differential (Class I - General Controls, product code JSH).

Submitted by Scott Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1977, 50 days after receiving the submission on October 17, 1977.

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

Submission Details

510(k) Number K771936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1977
Decision Date December 06, 1977
Days to Decision 50 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