Cleared Traditional

K850733 - MULTIPURPOSE CULTURE MEDIUM
(FDA 510(k) Clearance)

Mar 1985
Decision
28d
Days
Class 1
Risk

K850733 is an FDA 510(k) clearance for the MULTIPURPOSE CULTURE MEDIUM. This device is classified as a Culture Media, Non-selective And Non-differential (Class I - General Controls, product code JSG).

Submitted by Roseville Medical Laboratoriesu (Roseville, US). The FDA issued a Cleared decision on March 20, 1985, 28 days after receiving the submission on February 20, 1985.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2300.

Submission Details

510(k) Number K850733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1985
Decision Date March 20, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSG — Culture Media, Non-selective And Non-differential
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2300

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