Cleared Traditional

K823522 - DILULAB 230

K823522 is an FDA 510(k) clearance for DILULAB 230, manufactured by Innovative Medical Systems, Inc.. The device is a Class 1 Hematology device with product code GKH cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K823522 · Innovative Medical Systems, Inc. · Hematology device
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Dec 1982
Decision
29d
Days
Class 1
Risk

K823522 is an FDA 510(k) clearance for the DILULAB 230. Classified as Apparatus, Automated Blood Cell Diluting (product code GKH), Class I - General Controls.

Submitted by Innovative Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5240 - 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.

FDA 510(k) Submission Details - K823522

510(k) Number K823522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1982
Decision Date December 28, 1982
Days to Decision 29 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
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

GKH Device Classification - Class 1, General Controls

Product Code GKH Apparatus, Automated Blood Cell Diluting
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.5240
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.

Regulatory Peers - GKH Apparatus, Automated Blood Cell Diluting

All 13
Devices cleared under the same product code (GKH) and FDA review panel - the closest regulatory comparables to K823522.
AD150, AUTOMATED HEMATOLOGY DILUTOR
K852373 · Abbott Diagnostics · Jul 1985
HYCEL DILUTOR, VARIOUS MODELS/MULTI
K842747 · R&D Systems, Inc. · Oct 1984
DILU-MATIC 140
K842446 · Abbott Diagnostics · Sep 1984
ROYCO MODEL 371 SUPER DILUTOR
K791644 · Royco Instruments · Sep 1979
MICROSAMPLE BLOOD COLLECTION DEVICE
K761137 · Ortho Diagnostics, Inc. · Feb 1977
K823522 · DILULAB 230
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