Cleared Traditional

K842068 - IDI ISOTONIC DILUENT

K842068 is the FDA 510(k) clearance for IDI ISOTONIC DILUENT by Interscience Diagnostics, Inc.. It is a Class 1 Hematology device (product code GIF) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K842068 · Interscience Diagnostics, Inc. · Hematology device
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Jul 1984
Decision
40d
Days
Class 1
Risk

K842068 is an FDA 510(k) clearance for the IDI ISOTONIC DILUENT. Classified as Diluent, Blood Cell (product code GIF), Class I - General Controls.

Submitted by Interscience Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1984 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8200 - 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 Interscience Diagnostics, Inc. devices

Submission Details

510(k) Number K842068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1984
Decision Date July 02, 1984
Days to Decision 40 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 113d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GIF Diluent, Blood Cell
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8200
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 - GIF Diluent, Blood Cell

All 12
Devices cleared under the same product code (GIF) and FDA review panel - the closest regulatory comparables to K842068.
SYSMEX QUICKLYSER-II (QLS-200A)
K882267 · Toa Medical Electronics USA, Inc. · Jul 1988
SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-
K850239 · Toa Medical Electronics USA, Inc. · Apr 1985
HAYEM DILUTING FLUID
K842929 · E K Ind., Inc. · Sep 1984
UNITIZED HEMATOLOGY SET 65132/93
K840477 · Emd Chemicals, Inc. · Mar 1984
REAGENT FOR COULTER COUNTER MODEL 5+11
K821683 · Fisher Scientific Co., LLC · Jun 1982
MODIFIED BLOOD CELL COUNTING & LYSING
K801357 · Coulter Electronics, Inc. · Aug 1980