Cleared Traditional

K844708 - TRI-COUNT CALIBRATOR

K844708 is an FDA 510(k) clearance for TRI-COUNT CALIBRATOR, manufactured by Hematology Marketing Assoc.. The device is a Class 2 Hematology device with product code KSA cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K844708 · Hematology Marketing Assoc. · Hematology device
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Mar 1985
Decision
92d
Days
Class 2
Risk

K844708 is an FDA 510(k) clearance for the TRI-COUNT CALIBRATOR. Classified as Calibrator For Red-cell And White-cell Counting (product code KSA), Class II - Special Controls.

Submitted by Hematology Marketing Assoc. (Concord, US). The FDA issued a Cleared decision on March 5, 1985 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8185 - 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 Hematology Marketing Assoc. devices

FDA 510(k) Submission Details - K844708

510(k) Number K844708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1984
Decision Date March 05, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 113d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KSA Device Classification - Class 2, Special Controls

Product Code KSA Calibrator For Red-cell And White-cell Counting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8185
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 - KSA Calibrator For Red-cell And White-cell Counting

All 7
Devices cleared under the same product code (KSA) and FDA review panel - the closest regulatory comparables to K844708.
TECH-CAL(TM)/MULTIPLE
K881161 · R&D Systems, Inc. · May 1988
H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
K864664 · Technicon Instruments Corp. · Feb 1987
CBC-CAL/MULTIPLE
K854823 · R&D Systems, Inc. · Feb 1986
HEMOTOLOGY CALIBRATOR
K813530 · American Dade · Feb 1982
HEMATOLOGY CALIBRATOR S-CAL
K813375 · Coulter Electronics, Inc. · Feb 1982