Cleared Traditional

K873542 - MICROPLATE AUTO-WASHER (MOTORIZED STAGE)
(FDA 510(k) Clearance)

Sep 1987
Decision
22d
Days
Class 1
Risk

K873542 is an FDA 510(k) clearance for the MICROPLATE AUTO-WASHER (MOTORIZED STAGE). This device is classified as 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 September 23, 1987, 22 days after receiving the submission on September 1, 1987.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2500.

Submission Details

510(k) Number K873542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1987
Decision Date September 23, 1987
Days to Decision 22 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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