Cleared Traditional

K862066 - TITERTEK MICROPLATE WASHER S-12
(FDA 510(k) Clearance)

Jun 1986
Decision
6d
Days
Class 1
Risk

K862066 is an FDA 510(k) clearance for the TITERTEK MICROPLATE WASHER S-12. This device is classified as a Device, Microtiter Diluting/dispensing (Class I - General Controls, product code JTC).

Submitted by Flow Laboratories, Inc. (Mclean, US). The FDA issued a Cleared decision on June 5, 1986, 6 days after receiving the submission on May 30, 1986.

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

Submission Details

510(k) Number K862066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1986
Decision Date June 05, 1986
Days to Decision 6 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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