Cleared Traditional

GENETIC SYSTEMS MICROPLATE STRIP WASHER

K891766 · Genetic Systems Corp. · Microbiology
May 1989
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K891766 is an FDA 510(k) clearance for the GENETIC SYSTEMS MICROPLATE STRIP WASHER, a Device, Microtiter Diluting/dispensing (Class I — General Controls, product code JTC), submitted by Genetic Systems Corp. (Seattle, US). The FDA issued a Cleared decision on May 1, 1989, 38 days after receiving the submission on March 24, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2500.

Submission Details

510(k) Number K891766 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1989
Decision Date May 01, 1989
Days to Decision 38 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTC — Device, Microtiter Diluting/dispensing
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2500

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