Cleared Traditional

HEMATOLOGY ANALYZER (K842310) - FDA 510(k) Clearance

Class I Hematology device.

K842310 · Hml Inc/Biotechnology Transfer · Hematology device
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Sep 1984
Decision
86d
Days
Class 1
Risk

K842310 is an FDA 510(k) clearance for the HEMATOLOGY ANALYZER. Classified as Acid, Delta-aminolevulinic, Ion-exchange Columns With Colorimetry (product code JKL), Class I - General Controls.

Submitted by Hml Inc/Biotechnology Transfer (Mchenry, US). The FDA issued a Cleared decision on September 6, 1984 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1060 - 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 Hml Inc/Biotechnology Transfer devices

Submission Details

510(k) Number K842310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1984
Decision Date September 06, 1984
Days to Decision 86 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 113d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JKL Acid, Delta-aminolevulinic, Ion-exchange Columns With Colorimetry
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1060
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.