Cleared Traditional

WRIGHT STAIN

K842744 · E K Ind., Inc. · Pathology
Aug 1984
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K842744 is an FDA 510(k) clearance for the WRIGHT STAIN, a Wright's Stain (Class I — General Controls, product code IAF), submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1984, 30 days after receiving the submission on July 13, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K842744 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1984
Decision Date August 12, 1984
Days to Decision 30 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IAF — Wright's Stain
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850

Similar Devices — IAF Wright's Stain

All 32
WRIGHT-GLEMSA STAIN
K890673 · Sigma Diagnostics, Inc. · Feb 1989
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
K890674 · Sigma Diagnostics, Inc. · Feb 1989
HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS
K854236 · Nms Pharmaceuticals, Inc. · Oct 1986
CAMCO STAIN PAK
K860793 · Cambridge Chemical Products, Inc. · Mar 1986
HEMATOLOGY STAIN PACK
K853241 · Fisher Scientific Co., LLC · Aug 1985
WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S
K852138 · Canyon Diagnostics, Inc. · Jun 1985