Cleared Traditional

MINI MASH 2000

K854602 · Dynatech Corp. · Pathology
Dec 1985
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K854602 is an FDA 510(k) clearance for the MINI MASH 2000, a Device, General Purpose, Microbiology, Diagnostic (Class I — General Controls, product code LIB), submitted by Dynatech Corp. (Alexandria, US). The FDA issued a Cleared decision on December 6, 1985, 18 days after receiving the submission on November 18, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K854602 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1985
Decision Date December 06, 1985
Days to Decision 18 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code LIB — Device, General Purpose, Microbiology, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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