Cleared Traditional

K943336 - RETIC CONTROL-H HEMATOLOGY CONTROL/MULT...

K943336 is the FDA 510(k) clearance for RETIC CONTROL-H HEMATOLOGY CONTROL/MULT... by R&D Systems, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K943336 · R&D Systems, Inc. · Hematology device
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Dec 1994
Decision
153d
Days
Class 2
Risk

K943336 is an FDA 510(k) clearance for the RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 12, 1994 after a review of 153 days - an extended review cycle.

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 R&D Systems, Inc. devices

Submission Details

510(k) Number K943336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1994
Decision Date December 12, 1994
Days to Decision 153 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 113d · This submission: 153d
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 133
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K943336.
AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II
K952720 · Aalto Scientific, Ltd. · Sep 1995
SF-CHECK
K952245 · Streck Laboratories, Inc. · Sep 1995
RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE
K943335 · R&D Systems, Inc. · Dec 1994
COULTER FLOW SET
K944751 · Coulter Corp. · Dec 1994
CBC-LINE HEMATOLOGY LINEARITY CONTROL
K942822 · R&D Systems, Inc. · Oct 1994
PARA 5 DIFF
K935196 · Streck Laboratories, Inc. · Apr 1994