Cleared Traditional

MYWASHER 5

K853285 · Scientific Sales Intl., Inc. · Microbiology
Oct 1985
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K853285 is an FDA 510(k) clearance for the MYWASHER 5, a Device, General Purpose, Microbiology, Diagnostic (Class I — General Controls, product code LIB), submitted by Scientific Sales Intl., Inc. (Kalamazoo, US). The FDA issued a Cleared decision on October 4, 1985, 60 days after receiving the submission on August 5, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K853285 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1985
Decision Date October 04, 1985
Days to Decision 60 days
Submission Type Traditional
Review Panel Microbiology (MI)
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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