Cleared Traditional

K791929 - WRIGHTS RAPID STAIN

K791929 is an FDA 510(k) clearance for WRIGHTS RAPID STAIN, manufactured by Mcb Manufacturing Chemists, Inc.. The device is a Class 1 Hematology device with product code IAF cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K791929 · Mcb Manufacturing Chemists, Inc. · Hematology device
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Oct 1979
Decision
14d
Days
Class 1
Risk

K791929 is an FDA 510(k) clearance for the WRIGHTS RAPID STAIN. Classified as Wright's Stain (product code IAF), Class I - General Controls.

Submitted by Mcb Manufacturing Chemists, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 11, 1979 after a review of 14 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.

FDA 510(k) Submission Details - K791929

510(k) Number K791929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1979
Decision Date October 11, 1979
Days to Decision 14 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
99d faster than avg
Panel avg: 113d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

IAF Device Classification - Class 1, General Controls

Product Code IAF Wright's Stain
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 - IAF Wright's Stain

All 32
Devices cleared under the same product code (IAF) and FDA review panel - the closest regulatory comparables to K791929.
VOLU-SOL STATIM STAIN
K792497 · Volu Sol Medical Industries · Dec 1979
WRIGHTS RAPID STAIN
K792026 · Mcb Manufacturing Chemists, Inc. · Nov 1979
VOLU-SOL STAT STAIN
K792017 · Volu Sol Medical Industries · Oct 1979
QUIK-STAIN
K790571 · Dade, Baxter Travenol Diagnostics, Inc. · Apr 1979
HEMATOLOGY STAIN PACK
K781587 · Bioscientific · Oct 1978
CAMCO QUIK STAIN II
K781347 · Cambridge Chemical Products, Inc. · Aug 1978
K791929 · WRIGHTS RAPID STAIN
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