Cleared Traditional

K843962 - CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE

K843962 is the FDA 510(k) clearance for CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE by R&D Systems, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K843962 · R&D Systems, Inc. · Hematology device
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Nov 1984
Decision
21d
Days
Class 2
Risk

K843962 is an FDA 510(k) clearance for the CBC-PLT-4 WHOLE BLOOD 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 November 1, 1984 after a review of 21 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all R&D Systems, Inc. devices

Submission Details

510(k) Number K843962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1984
Decision Date November 01, 1984
Days to Decision 21 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
92d faster than avg
Panel avg: 113d · This submission: 21d
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 K843962.
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
K850755 · R&D Systems, Inc. · May 1985
TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH
K850250 · Technicon Instruments Corp. · Apr 1985
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
K843805 · Coulter Electronics, Inc. · Dec 1984
RETIC-CHEX
K843093 · Streck Laboratories, Inc. · Oct 1984
PARA-TEK
K841531 · Streck Laboratories, Inc. · Jul 1984
TECHNICON TEST POINT ASSAYED HEMATOLOGY
K842109 · Technicon Instruments Corp. · Jul 1984