Cleared Traditional

K840477 - UNITIZED HEMATOLOGY SET 65132/93

K840477 is an FDA 510(k) clearance for UNITIZED HEMATOLOGY SET 65132/93, manufactured by Emd Chemicals, Inc.. The device is a Class 1 Hematology device with product code GIF cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K840477 · Emd Chemicals, Inc. · Hematology device
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Mar 1984
Decision
31d
Days
Class 1
Risk

K840477 is an FDA 510(k) clearance for the UNITIZED HEMATOLOGY SET 65132/93. Classified as Diluent, Blood Cell (product code GIF), Class I - General Controls.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984 after a review of 31 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.

FDA 510(k) Submission Details - K840477

510(k) Number K840477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1984
Decision Date March 05, 1984
Days to Decision 31 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
82d faster than avg
Panel avg: 113d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

GIF Device Classification - Class 1, General Controls

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 37
Devices cleared under the same product code (GIF) and FDA review panel - the closest regulatory comparables to K840477.
IDI ISOTONIC DILUENT
K842068 · Interscience Diagnostics, Inc. · Jul 1984
CYANOMETHEMOGLOBIN REAGENT
K841799 · Reagent Laboratory, Inc. · May 1984
SDI PREPAX DILUKIT HW
K840041 · Scientific Distributors, Inc. · Mar 1984
QUICK-COUNT HEMATOLOGY REAGENT KIT
K833972 · Seragen Diagnostics, Inc. · Feb 1984
PREPAX DILUKIT PLUS
K840038 · Scientific Distributors, Inc. · Feb 1984
SDI PREPAX DILUKIT CT
K840043 · Scientific Distributors, Inc. · Feb 1984
K840477 · UNITIZED HEMATOLOGY SET 65132/93
Download PDF Emd Chemicals, Inc.