Cleared Traditional

K791007 - STAT DIFF STAIN

K791007 is an FDA 510(k) clearance for STAT DIFF STAIN, manufactured by Bioscientific. The device is a Class 1 Hematology device with product code KQC cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K791007 · Bioscientific · Hematology device
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Aug 1979
Decision
64d
Days
Class 1
Risk

K791007 is an FDA 510(k) clearance for the STAT DIFF STAIN. Classified as Stains, Hematology (product code KQC), Class I - General Controls.

Submitted by Bioscientific (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.1850 - 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 Bioscientific devices

FDA 510(k) Submission Details - K791007

510(k) Number K791007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1979
Decision Date August 03, 1979
Days to Decision 64 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 113d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

KQC Device Classification - Class 1, General Controls

Product Code KQC Stains, Hematology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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 - KQC Stains, Hematology

All 7
Devices cleared under the same product code (KQC) and FDA review panel - the closest regulatory comparables to K791007.
RETIC-SET
K841848 · R&D Systems, Inc. · May 1984
PONCEAU S STAIN SET
K792550 · Electrophoresis Corp. of America · Jan 1980
VOLU-SOL NMB RETICULOCYTE STAIN
K792496 · Volu Sol Medical Industries · Dec 1979
HEMASTAIN FIXATIVE
K760485 · Geometric Data, Div. Smithkline Corp. · Aug 1976
HEMASTAIN PHOSPHATE BUFFER
K760487 · Geometric Data, Div. Smithkline Corp. · Aug 1976