Cleared Traditional

K832116 - ATAC 4700 HEMATOLOGY CELL COUNTER

K832116 is an FDA 510(k) clearance for ATAC 4700 HEMATOLOGY CELL COUNTER, manufactured by Turpen Laboratory Systems, Inc.. The device is a Class 1 Hematology device with 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.

FDA 510(k) Submission Details - K832116

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 113d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

GIF Device Classification - Class 1, General Controls

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 37
Devices cleared under the same product code (GIF) and FDA review panel - the closest regulatory comparables to K832116.
PREPAX DILUKIT PLUS
K840038 · Scientific Distributors, Inc. · Feb 1984
SDI PREPAX DILUKIT CT
K840043 · Scientific Distributors, Inc. · Feb 1984
ISOTONIC BLOOD CELL DILUENT J & S
K833443 · Jasins & Sayles Associates, Inc. · Nov 1983
DILUENT
K831617 · Omega Medical Diagnostics · Jun 1983
OSMOCEL +
K830188 · Hematology Marketing Assoc. · Mar 1983
BLOOD CELL DILUENT 78N 1913
K822325 · Interscience, Inc. · Oct 1982
K832116 · ATAC 4700 HEMATOLOGY CELL COUNTER
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