Cleared Traditional

K935343 - CENTRIFIQ BLOOD CONTROL

K935343 is the FDA 510(k) clearance for CENTRIFIQ BLOOD CONTROL by Hematronix, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K935343 · Hematronix, Inc. · Hematology device
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Jan 1994
Decision
128d
Days
Class 2
Risk

K935343 is an FDA 510(k) clearance for the CENTRIFIQ BLOOD CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Hematronix, Inc. (Plano, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 Hematronix, Inc. devices

Submission Details

510(k) Number K935343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1993
Decision Date January 27, 1994
Days to Decision 128 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 113d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JPK Mixture, Hematology Quality Control

All 134
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K935343.
PARA 5 DIFF
K935196 · Streck Laboratories, Inc. · Apr 1994
CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE
K940089 · R&D Systems, Inc. · Mar 1994
SE-CHECK
K940181 · Streck Laboratories, Inc. · Mar 1994
CHECKPOINT
K931947 · Medical Specialties, Inc. · Jun 1993
COULTER RETIC-C CELL CONTROL
K930119 · Coulter Electronics, Inc. · Apr 1993
QC-CHEX
K923971 · Streck Laboratories, Inc. · Nov 1992