Cleared Traditional

K962687 - GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC...

K962687 is the FDA 510(k) clearance for GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC... by Nichols Institute Diagnostics. It is a Class 1 Hematology device (product code JQW) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K962687 · Nichols Institute Diagnostics · Hematology device
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Mar 1997
Decision
260d
Days
Class 1
Risk

K962687 is an FDA 510(k) clearance for the GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 260 days - an extended review cycle.

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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K962687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1996
Decision Date March 28, 1997
Days to Decision 260 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
147d slower than avg
Panel avg: 113d · This submission: 260d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 63
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