Cleared Traditional

K935343 - CENTRIFIQ BLOOD CONTROL

K935343 is an FDA 510(k) clearance for CENTRIFIQ BLOOD CONTROL, manufactured by Hematronix, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K935343

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.

JPK Device Classification - Class 2, Special Controls

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 167
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