Cleared Traditional

REPLICA PLATER

K810719 · Dynatech Corp. · Hematology
Apr 1981
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K810719 is an FDA 510(k) clearance for the REPLICA PLATER, a Device, Microtiter Diluting/dispensing (Class I — General Controls, product code JTC), submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on April 1, 1981, 15 days after receiving the submission on March 17, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 866.2500.

Submission Details

510(k) Number K810719 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1981
Decision Date April 01, 1981
Days to Decision 15 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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