Cleared Traditional

K850755 - CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLO...

K850755 is the FDA 510(k) clearance for CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLO... by R&D Systems, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K850755 · R&D Systems, Inc. · Hematology device
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May 1985
Decision
77d
Days
Class 2
Risk

K850755 is an FDA 510(k) clearance for the CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL. 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 May 13, 1985 after a review of 77 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 K850755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1985
Decision Date May 13, 1985
Days to Decision 77 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
36d faster than avg
Panel avg: 113d · This submission: 77d
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 K850755.
PLATELET-TROL II
K854353 · R&D Systems, Inc. · Nov 1985
PARA CHECK (AKA EIGHT CHECK-C)
K852992 · Streck Laboratories, Inc. · Oct 1985
MSI-HB HEMOGLOBIN CONTROL
K853776 · Medical Specialties, Inc. · Sep 1985
TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH
K850250 · Technicon Instruments Corp. · Apr 1985
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
K843805 · Coulter Electronics, Inc. · Dec 1984
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
K843962 · R&D Systems, Inc. · Nov 1984