Cleared Traditional

PLATE INCUBATOR

K853379 · Scientific Sales Intl., Inc. · Microbiology
Sep 1985
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K853379 is an FDA 510(k) clearance for the PLATE INCUBATOR, a Bath, Incubators/water, All (Class I — General Controls, product code JTQ), submitted by Scientific Sales Intl., Inc. (Kalamazoo, US). The FDA issued a Cleared decision on September 3, 1985, 22 days after receiving the submission on August 12, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2540.

Submission Details

510(k) Number K853379 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1985
Decision Date September 03, 1985
Days to Decision 22 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTQ — Bath, Incubators/water, All
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2540

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