Cleared Traditional

K821683 - REAGENT FOR COULTER COUNTER MODEL 5+11 (FDA 510(k) Clearance)

Class I Hematology device.

K821683 · Fisher Scientific Co., LLC · Hematology device
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Jun 1982
Decision
16d
Days
Class 1
Risk

K821683 is an FDA 510(k) clearance for the REAGENT FOR COULTER COUNTER MODEL 5+11. Classified as Diluent, Blood Cell (product code GIF), Class I - General Controls.

Submitted by Fisher Scientific Co., LLC (Walker, US). The FDA issued a Cleared decision on June 24, 1982 after a review of 16 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 Fisher Scientific Co., LLC devices

Submission Details

510(k) Number K821683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1982
Decision Date June 24, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 113d · This submission: 16d
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.