Cleared Traditional

K840010 - DADE HEMATOLOGY CALIBRATOR PLUS

K840010 is the FDA 510(k) clearance for DADE HEMATOLOGY CALIBRATOR PLUS by American Dade. It is a Class 2 Hematology device (product code KRZ) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K840010 · American Dade · Hematology device
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Apr 1984
Decision
106d
Days
Class 2
Risk

K840010 is an FDA 510(k) clearance for the DADE HEMATOLOGY CALIBRATOR PLUS. Classified as Calibrator For Hemoglobin And Hematocrit Measurement (product code KRZ), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on April 19, 1984 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8165 - 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.

View all American Dade devices

Submission Details

510(k) Number K840010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1984
Decision Date April 19, 1984
Days to Decision 106 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
7d faster than avg
Panel avg: 113d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRZ Calibrator For Hemoglobin And Hematocrit Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8165
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 - KRZ Calibrator For Hemoglobin And Hematocrit Measurement

All 12
Devices cleared under the same product code (KRZ) and FDA review panel - the closest regulatory comparables to K840010.
MSI-CAL 16
K883850 · Medical Specialties, Inc. · Nov 1988
MSI-CAL 8
K883851 · Medical Specialties, Inc. · Nov 1988
QCA HEMOGLOBIN KIT
K843695 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1984
CAL-CHEX, A HEMATOLOGY CALIBRATOR
K840261 · Streck Laboratories, Inc. · Feb 1984
CALIBRATOR 282
K831872 · Bionostics, Inc. · Jul 1983
SERALYZER HEMOGLOBIN CALIBRATORS
K822046 · Miles Laboratories, Inc. · Jul 1982