Cleared Traditional

K833972 - QUICK-COUNT HEMATOLOGY REAGENT KIT

K833972 is the FDA 510(k) clearance for QUICK-COUNT HEMATOLOGY REAGENT KIT by Seragen Diagnostics, Inc.. It is a Class 1 Hematology device (product code GIF) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

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.

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 K833972.
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
ISOTONIC DILUENT
K781008 · Mallinckrodt Critical Care · Jun 1978