Cleared Traditional

STAT STAIN SET

K810495 · Accra Laboratories, Inc. · Pathology
Mar 1981
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K810495 is an FDA 510(k) clearance for the STAT STAIN SET, a Wright's Stain (Class I — General Controls, product code IAF), submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1981, 21 days after receiving the submission on February 24, 1981. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K810495 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1981
Decision Date March 17, 1981
Days to Decision 21 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