Cleared Traditional

K810756 - HEMOTOLOGY QUALITY CONTROL MIXTURES

K810756 is an FDA 510(k) clearance for HEMOTOLOGY QUALITY CONTROL MIXTURES, manufactured by Scientific Standards, Inc.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K810756 · Scientific Standards, Inc. · Hematology device
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Jun 1981
Decision
102d
Days
Class 2
Risk

K810756 is an FDA 510(k) clearance for the HEMOTOLOGY QUALITY CONTROL MIXTURES. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Scientific Standards, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1981 after a review of 102 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.

FDA 510(k) Submission Details - K810756

510(k) Number K810756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1981
Decision Date June 30, 1981
Days to Decision 102 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 113d · This submission: 102d
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 185
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K810756.
HEMOTOLOGY QUALITY CONTROL MIXTURE
K812237 · American Dade · Sep 1981
HEMATOLOGY CONTROL
K812280 · American Dade · Sep 1981
VENTREX DATA REDUCTION & QUAL. CONTR. SY
K812357 · Ventrex Laboratories, Inc. · Sep 1981
THROMBO-TEST (X)
K801054 · Medtro GmbH · Mar 1981
CBC PLT-4
K802265 · R&D Systems, Inc. · Nov 1980
PLT-4 SIZE-CHECK
K802267 · R&D Systems, Inc. · Nov 1980
K810756 · HEMOTOLOGY QUALITY CONTROL MIXTURES
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