Cleared Traditional

K862802 - MULTI-CHANNEL MICROPIPETTES
(FDA 510(k) Clearance)

K862802 · Dynatech Laboratories, Inc. · Hematology
Aug 1986
Decision
10d
Days
Class 1
Risk

K862802 is an FDA 510(k) clearance for the MULTI-CHANNEL MICROPIPETTES, a Device, Microtiter Diluting/dispensing (Class I — General Controls, product code JTC), submitted by Dynatech Laboratories, Inc. (Chantilly, US). The FDA issued a Cleared decision on August 1, 1986, 10 days after receiving the submission on July 22, 1986. This device falls under the Hematology review panel. Regulated under 21 CFR 866.2500.

Submission Details

510(k) Number K862802 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1986
Decision Date August 01, 1986
Days to Decision 10 days
Submission Type Traditional
Review Panel Hematology (HE)
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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