Cleared Traditional

K831605 - HEMATOLOGY PAK

K831605 is an FDA 510(k) clearance for HEMATOLOGY PAK, manufactured by Mercedes Scientific Co., Inc.. The device is a Class 1 Hematology device with product code IAF cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K831605 · Mercedes Scientific Co., Inc. · Hematology device
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Jun 1983
Decision
43d
Days
Class 1
Risk

K831605 is an FDA 510(k) clearance for the HEMATOLOGY PAK. Classified as Wright's Stain (product code IAF), Class I - General Controls.

Submitted by Mercedes Scientific Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 43 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 Mercedes Scientific Co., Inc. devices

FDA 510(k) Submission Details - K831605

510(k) Number K831605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1983
Decision Date June 30, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 113d · This submission: 43d
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 19
Devices cleared under the same product code (IAF) and FDA review panel - the closest regulatory comparables to K831605.
WRIGHT STAIN
K842744 · E K Ind., Inc. · Aug 1984
WRIGHT-GIEMSA QUICK STAIN
K842745 · E K Ind., Inc. · Aug 1984
HEMATOLOGY WRIGHT'S STAIN PACK
K833678 · J.S. Medical Assoc. · Nov 1983
HEMAQUIK II STAINING SOLUTION #55961
K830542 · Accra Laboratories, Inc. · Mar 1983
MIDAS 1000 WRIGHT STAIN #66010
K822980 · Emd Chemicals, Inc. · Oct 1982
MIDAS 1000 WRIGHT GIEMSA STAIN #66020
K822981 · Emd Chemicals, Inc. · Oct 1982