Cleared Traditional

FILTERMATE UNIVERSAL HARVESTER

K924907 · Packard Instrument Co., Inc. · Hematology
Dec 1992
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K924907 is an FDA 510(k) clearance for the FILTERMATE UNIVERSAL HARVESTER, a Device, Microtiter Diluting/dispensing (Class I — General Controls, product code JTC), submitted by Packard Instrument Co., Inc. (Downers Grove, US). The FDA issued a Cleared decision on December 1, 1992, 63 days after receiving the submission on September 29, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 866.2500.

Submission Details

510(k) Number K924907 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1992
Decision Date December 01, 1992
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

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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