Cleared Traditional

GENETIC SYSTEMS MICROPLATE WASHER

K891768 · Genetic Systems Corp. · Microbiology
May 1989
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K891768 is an FDA 510(k) clearance for the GENETIC SYSTEMS MICROPLATE 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 K891768 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

Similar Devices — JTC Device, Microtiter Diluting/dispensing

All 65
FILTERMATE UNIVERSAL HARVESTER
K924907 · Packard Instrument Co., Inc. · Dec 1992
MICROMATE 196 MODEL A961960
K901808 · Packard Instrument Co., Inc. · Jun 1990
IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM
K894645 · Dynatech Laboratories, Inc. · Oct 1989
MULTI-PROBE HEAD PLUS
K892369 · Hamilton Co. · Jun 1989
GENETIC SYSTEMS PIPETTOR/DILUTOR
K891765 · Genetic Systems Corp. · May 1989
GENETIC SYSTEMS MICROPLATE STRIP WASHER
K891766 · Genetic Systems Corp. · May 1989