IAF · Class I · 21 CFR 864.1850

FDA Product Code IAF: Wright's Stain

Leading manufacturers include Accra Laboratories, Inc., Volu Sol Medical Industries and Emd Chemicals, Inc..

33
Total
33
Cleared
36d
Avg days
1976
Since

FDA 510(k) Cleared Wright's Stain Devices (Product Code IAF)

33 devices
1–24 of 33
Cleared Feb 24, 1989
WRIGHT-GLEMSA STAIN
K890673
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Feb 24, 1989
ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET
K890674
Sigma Diagnostics, Inc.
Pathology · 15d
Cleared Aug 19, 1985
HEMATOLOGY STAIN PACK
K853241
Fisher Scientific Co., LLC
Pathology · 18d
Cleared Aug 12, 1984
WRIGHT STAIN
K842744
E K Ind., Inc.
Pathology · 30d
Cleared Aug 10, 1984
WRIGHT-GIEMSA QUICK STAIN
K842745
E K Ind., Inc.
Pathology · 28d
Cleared Nov 25, 1983
HEMATOLOGY WRIGHT'S STAIN PACK
K833678
J.S. Medical Assoc.
Hematology · 38d
Cleared Mar 17, 1983
HEMAQUIK II STAINING SOLUTION #55961
K830542
Accra Laboratories, Inc.
Pathology · 23d
Cleared Oct 27, 1982
MIDAS 1000 WRIGHT STAIN #66010
K822980
Emd Chemicals, Inc.
Hematology · 19d
Cleared Oct 27, 1982
MIDAS 1000 WRIGHT GIEMSA STAIN #66020
K822981
Emd Chemicals, Inc.
Hematology · 19d
Cleared Jun 01, 1982
HEMACOUNT WRIGHTS STAIN PACK II #55952
K821457
Accra Laboratories, Inc.
Hematology · 15d
Cleared Mar 26, 1982
AVES WRIGHT STAIN
K820437
Helena Laboratories
Pathology · 37d
Cleared Oct 23, 1981
ACCRA LAB HEMOTOLOGY
K812848
Accra Laboratories, Inc.
Pathology · 14d
Cleared Sep 23, 1981
ACCRA LAB WRIGHT STAIN
K812504
Accra Laboratories, Inc.
Pathology · 22d
Cleared Jun 18, 1981
HEMAQUIK
K811400
Accra Laboratories, Inc.
Pathology · 31d
Cleared Mar 17, 1981
STAT STAIN SET
K810495
Accra Laboratories, Inc.
Pathology · 21d
Cleared Dec 18, 1979
VOLU-SOL STATIM STAIN
K792497
Volu Sol Medical Industries
Pathology · 14d
Cleared Oct 30, 1979
VOLU-SOL STAT STAIN
K792017
Volu Sol Medical Industries
Hematology · 21d
Cleared Apr 23, 1979
QUIK-STAIN
K790571
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 31d
Cleared Jul 20, 1976
DSP - STAIN PACK
K760027
Harleco
Hematology · 36d

About Product Code IAF - Regulatory Context