Cleared Traditional

K844042 - BLOOD DILUTION VIAL

K844042 is an FDA 510(k) clearance for BLOOD DILUTION VIAL, manufactured by American Scientific Products. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K844042 · American Scientific Products · Hematology device
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Oct 1984
Decision
6d
Days
Class 2
Risk

K844042 is an FDA 510(k) clearance for the BLOOD DILUTION VIAL. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by American Scientific Products (Waukegan, US). The FDA issued a Cleared decision on October 23, 1984 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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 Scientific Products devices

FDA 510(k) Submission Details - K844042

510(k) Number K844042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1984
Decision Date October 23, 1984
Days to Decision 6 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
107d faster than avg
Panel avg: 113d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 97
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K844042.
CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER
K845019 · Abbott Diagnostics · Mar 1985
COULTER COUNTER MODEL M4
K843303 · Coulter Electronics, Inc. · Dec 1984
COULTER COUNTER MODEL ZM
K843164 · Coulter Electronics, Inc. · Nov 1984
PICOSCAL BLOOD CELL COUNTER PS-4
K842140 · Diagnostic Technology, Inc. · Aug 1984
COULTER AUTOMATIC SAMPLE HANDLER
K842346 · Coulter Electronics, Inc. · Jul 1984
QUICK-COUNT PLUS 2
K841504 · Seragen Diagnostics, Inc. · Jun 1984