Cleared Traditional

GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM

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

About This 510(k) Submission

K962687 is an FDA 510(k) clearance for the GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on March 28, 1997, 260 days after receiving the submission on July 11, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K962687 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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