Cleared Traditional

K812280 - HEMATOLOGY CONTROL

K812280 is the FDA 510(k) clearance for HEMATOLOGY CONTROL by American Dade. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K812280 · American Dade · Hematology device
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Sep 1981
Decision
27d
Days
Class 2
Risk

K812280 is an FDA 510(k) clearance for the HEMATOLOGY CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on September 9, 1981 after a review of 27 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 American Dade devices

Submission Details

510(k) Number K812280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1981
Decision Date September 09, 1981
Days to Decision 27 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
86d faster than avg
Panel avg: 113d · This submission: 27d
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 K812280.
HEMATALL-C PLUS HEMATOLOGY CONTROLS
K820731 · Fisher Scientific Co., LLC · May 1982
ORTHO* HEMATOLOGY CONTROL 8 NORMAL
K820400 · Ortho Diagnostic Systems, Inc. · Mar 1982
HEMOTOLOGY QUALITY CONTROL MIXTURE
K812237 · American Dade · Sep 1981
VENTREX DATA REDUCTION & QUAL. CONTR. SY
K812357 · Ventrex Laboratories, Inc. · Sep 1981
CBC PLT-4
K802265 · R&D Systems, Inc. · Nov 1980
PLT-4 SIZE-CHECK
K802267 · R&D Systems, Inc. · Nov 1980