Cleared Traditional

QUICK-COUNT HEMATOLOGY REAGENT KIT (K833972) - FDA 510(k) Clearance

Class I Hematology device.

K833972 · Seragen Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
93d
Days
Class 1
Risk

K833972 is an FDA 510(k) clearance for the QUICK-COUNT HEMATOLOGY REAGENT KIT. Classified as Diluent, Blood Cell (product code GIF), Class I - General Controls.

Submitted by Seragen Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1984 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Seragen Diagnostics, Inc. devices

Submission Details

510(k) Number K833972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1983
Decision Date February 17, 1984
Days to Decision 93 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 113d · This submission: 93d
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.