Cleared Traditional

MUCOLYSE

K850300 · Pro-Lab, Inc. · Microbiology
Mar 1985
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K850300 is an FDA 510(k) clearance for the MUCOLYSE, a Supplement, Culture Media (Class I — General Controls, product code JSK), submitted by Pro-Lab, Inc. (Ontario Canada M5m 1c9, CA). The FDA issued a Cleared decision on March 20, 1985, 57 days after receiving the submission on January 22, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2450.

Submission Details

510(k) Number K850300 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1985
Decision Date March 20, 1985
Days to Decision 57 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSK — Supplement, Culture Media
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2450

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