Cleared Traditional

K844568 - TITERTEK DULUTER/DISPENSER 78-640-00 (FDA 510(k) Clearance)

Jan 1985
Decision
68d
Days
Class 1
Risk

K844568 is an FDA 510(k) clearance for the TITERTEK DULUTER/DISPENSER 78-640-00. 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 January 30, 1985, 68 days after receiving the submission on November 23, 1984.

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

Submission Details

510(k) Number K844568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1984
Decision Date January 30, 1985
Days to Decision 68 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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