Cleared Traditional

ATAC 4700 HEMATOLOGY CELL COUNTER (K832116) - FDA 510(k) Clearance

Class I Hematology device.

K832116 · Turpen Laboratory Systems, Inc. · Hematology device
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Oct 1983
Decision
112d
Days
Class 1
Risk

K832116 is an FDA 510(k) clearance for the ATAC 4700 HEMATOLOGY CELL COUNTER. Classified as Diluent, Blood Cell (product code GIF), Class I - General Controls.

Submitted by Turpen Laboratory Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1983 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8200 - 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 Turpen Laboratory Systems, Inc. devices

Submission Details

510(k) Number K832116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1983
Decision Date October 20, 1983
Days to Decision 112 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 113d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GIF Diluent, Blood Cell
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8200
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.