Cleared Traditional

K832116 - ATAC 4700 HEMATOLOGY CELL COUNTER

K832116 is the FDA 510(k) clearance for ATAC 4700 HEMATOLOGY CELL COUNTER by Turpen Laboratory Systems, Inc.. It is a Class 1 Hematology device (product code GIF) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

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.

Regulatory Peers - GIF Diluent, Blood Cell

All 12
Devices cleared under the same product code (GIF) and FDA review panel - the closest regulatory comparables to K832116.
SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-
K850239 · Toa Medical Electronics USA, Inc. · Apr 1985
HAYEM DILUTING FLUID
K842929 · E K Ind., Inc. · Sep 1984
UNITIZED HEMATOLOGY SET 65132/93
K840477 · Emd Chemicals, Inc. · Mar 1984
REAGENT FOR COULTER COUNTER MODEL 5+11
K821683 · Fisher Scientific Co., LLC · Jun 1982
MODIFIED BLOOD CELL COUNTING & LYSING
K801357 · Coulter Electronics, Inc. · Aug 1980
ISOTONIC DILUENT
K781008 · Mallinckrodt Critical Care · Jun 1978