Cleared Traditional

SUPLEX & SUPLEX DILUENT

K850302 · Pro-Lab, Inc. · Microbiology
Mar 1985
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K850302 is an FDA 510(k) clearance for the SUPLEX & SUPLEX DILUENT, 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 22, 1985, 59 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 K850302 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1985
Decision Date March 22, 1985
Days to Decision 59 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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