Cleared Traditional

K843805 - COULTER CHECK SAMPLE UNASSAYED HEMATOLOG

K843805 is an FDA 510(k) clearance for COULTER CHECK SAMPLE UNASSAYED HEMATOLOG, 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 81-day FDA review.

K843805 · Coulter Electronics, Inc. · Hematology device
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Dec 1984
Decision
81d
Days
Class 2
Risk

K843805 is an FDA 510(k) clearance for the COULTER CHECK SAMPLE UNASSAYED HEMATOLOG. 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 December 17, 1984 after a review of 81 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 - K843805

510(k) Number K843805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1984
Decision Date December 17, 1984
Days to Decision 81 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
32d faster than avg
Panel avg: 113d · This submission: 81d
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 K843805.
TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH
K850250 · Technicon Instruments Corp. · Apr 1985
QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS
K844927 · Bhp Diagnostix, Inc. · Mar 1985
QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE
K844928 · Bhp Diagnostix, Inc. · Mar 1985
COUNT-A-PART PLUS
K841809 · Diagnostic Technology, Inc. · Nov 1984
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
K843962 · R&D Systems, Inc. · Nov 1984
RETIC-CHEX
K843093 · Streck Laboratories, Inc. · Oct 1984