Cleared Traditional

K924907 - FILTERMATE UNIVERSAL HARVESTER

K924907 is an FDA 510(k) clearance for FILTERMATE UNIVERSAL HARVESTER, manufactured by Packard Instrument Co., Inc.. The device is a Class 1 Hematology device with product code JTC cleared through the Traditional 510(k) pathway after a 63-day FDA review.

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

K924907 is an FDA 510(k) clearance for the FILTERMATE UNIVERSAL HARVESTER. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Packard Instrument Co., Inc. (Downers Grove, US). The FDA issued a Cleared decision on December 1, 1992 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.2500 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K924907

510(k) Number K924907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 113d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

JTC Device Classification - Class 1, General Controls

Product Code JTC Device, Microtiter Diluting/dispensing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JTC Device, Microtiter Diluting/dispensing

All 65
Devices cleared under the same product code (JTC) and FDA review panel - the closest regulatory comparables to K924907.
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K924907 · FILTERMATE UNIVERSAL HARVESTER
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