Cleared Special

K003208 - R & D 3K RETIC

K003208 is the FDA 510(k) clearance for R & D 3K RETIC by R&D Systems, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Special 510(k) pathway after a 25-day FDA review.

K003208 · R&D Systems, Inc. · Hematology device
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Nov 2000
Decision
25d
Days
Class 2
Risk

K003208 is an FDA 510(k) clearance for the R & D 3K RETIC. 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 November 7, 2000 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all R&D Systems, Inc. devices

Submission Details

510(k) Number K003208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2000
Decision Date November 07, 2000
Days to Decision 25 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 113d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K003208.
5C-ES CELL CONTROL, MODELS 7547191, 7547192
K010066 · Beckman Coulter, Inc. · Feb 2001
CBC-4K HEMATOLOGY CONTROL
K003874 · R&D Systems, Inc. · Jan 2001
PENTRA 5D
K003534 · R&D Systems, Inc. · Dec 2000
RETIC CHEX LINEARITY
K000115 · Streck Laboratories, Inc. · Mar 2000
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
K991876 · R&D Systems, Inc. · Jun 1999
IMMUNO-TROL CONTROL CELLS
K984216 · Coulter Corp. · Mar 1999