Cleared Traditional

K781969 - BLOOD, HEMATOLOGY REFERENCE CONTROL

K781969 is an FDA 510(k) clearance for BLOOD, manufactured by Coulter Electronics, Inc.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K781969 · Coulter Electronics, Inc. · Hematology device
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Jan 1979
Decision
40d
Days
Class 2
Risk

K781969 is an FDA 510(k) clearance for the BLOOD, HEMATOLOGY REFERENCE CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1979 after a review of 40 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 Coulter Electronics, Inc. devices

FDA 510(k) Submission Details - K781969

510(k) Number K781969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1978
Decision Date January 03, 1979
Days to Decision 40 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
73d faster than avg
Panel avg: 113d · This submission: 40d
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 166
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K781969.
COAGULATION ARP
K790826 · Helena Laboratories · May 1979
HEMOGLOBIN CONTROLS
K790457 · Data Medical Associates, Inc. · Apr 1979
HEMATROL S HEMATOLOGY CONTROLS
K790525 · Fisher Scientific Co., LLC · Apr 1979
QUANTICEL HHR, L531 AND L532
K781745 · Bhp Diagnostix, Inc. · Nov 1978
QUANTICEL HHR # L500 AND L501
K781786 · Bhp Diagnostix, Inc. · Nov 1978
NORMAL HEMATOLOGY CONTROL UNASSAYED
K781572 · Ortho Diagnostics, Inc. · Oct 1978