IAF · Class I · 21 CFR 864.1850

FDA Product Code IAF: Wright's Stain

Leading manufacturers include Volu Sol Medical Industries, Emd Chemicals, Inc. and E K Ind., 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 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 Mar 26, 1982
AVES WRIGHT STAIN
K820437
Helena Laboratories
Pathology · 37d
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