Cleared Traditional

K922327 - DENLEY WELLPREP 2 SAMPLE PROCESSOR

K922327 is an FDA 510(k) clearance for DENLEY WELLPREP 2 SAMPLE PROCESSOR, manufactured by Denley Instruments, Inc.. The device is a Class 1 Hematology device with product code JQW cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K922327 · Denley Instruments, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
93d
Days
Class 1
Risk

K922327 is an FDA 510(k) clearance for the DENLEY WELLPREP 2 SAMPLE PROCESSOR. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Denley Instruments, Inc. (Bethesda, US). The FDA issued a Cleared decision on August 12, 1992 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Denley Instruments, Inc. devices

FDA 510(k) Submission Details - K922327

510(k) Number K922327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1992
Decision Date August 12, 1992
Days to Decision 93 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 113d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 84
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