Wright'S Stain
FDA product code IAF · Class I (low risk) · 21 CFR 864.1850 · Hematology
33510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
- Accra Laboratories, Inc. 6
- Mcb Manufacturing Chemists, Inc. 3
- Jack W. Kindberg 2
- Sigma Diagnostics, Inc. 2
- E K Ind., Inc. 2
- Mercedes Scientific Co., Inc. 2
- Emd Chemicals, Inc. 2
- Volu Sol Medical Industries 2
- Cambridge Chemical Products, Inc. 2
- Dade, Baxter Travenol Diagnostics, Inc. 1
- Helena Laboratories 1
- Bioscientific 1
- Mfg Chemists, Inc. 1
- Wescor, Inc. 1
- J.S. Medical Assoc. 1
- Canyon Diagnostics, Inc. 1
- Fisher Scientific Co., LLC 1
- Nms Pharmaceuticals, Inc. 1
- Harleco 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890674 | Accustain(Tm) - Automated Wright Giemsa Stain SetIAF · Traditional | Sigma Diagnostics, Inc. | 02/24/1989SE |
| K890673 | Wright-Glemsa StainIAF · Traditional | Sigma Diagnostics, Inc. | 02/24/1989SE |
| K854236 | Histamine Ria Test for Histamine Biological FluidsIAF · Traditional | Nms Pharmaceuticals, Inc. | 10/10/1986SN |
| K860793 | Camco Stain PakIAF · Traditional | Cambridge Chemical Products, Inc. | 03/18/1986SE |
| K853241 | Hematology Stain PackIAF · Traditional | Fisher Scientific Co., LLC | 08/19/1985SE |
| K852138 | Wescor Stain Pack for Model 7100 Aerospray Slide SIAF · Traditional | Canyon Diagnostics, Inc. | 06/13/1985SE |
| K842744 | Wright StainIAF · Traditional | E K Ind., Inc. | 08/12/1984SE |
| K842745 | Wright-Giemsa Quick StainIAF · Traditional | E K Ind., Inc. | 08/10/1984SE |
| K833678 | Hematology Wright's Stain PackIAF · Traditional | J.S. Medical Assoc. | 11/25/1983SE |
| K833260 | Stain Pack for Aerospray Slide StainerIAF · Traditional | Wescor, Inc. | 10/28/1983SE |
| K831605 | Hematology PakIAF · Traditional | Mercedes Scientific Co., Inc. | 06/30/1983SE |
| K830542 | Hemaquik II Staining Solution #55961IAF · Traditional | Accra Laboratories, Inc. | 03/17/1983SE |
| K830127 | Quik-Dip Blood StainIAF · Traditional | Mercedes Scientific Co., Inc. | 02/15/1983SE |
| K822981 | Midas 1000 Wright Giemsa Stain #66020IAF · Traditional | Emd Chemicals, Inc. | 10/27/1982SE |
| K822980 | Midas 1000 Wright Stain #66010IAF · Traditional | Emd Chemicals, Inc. | 10/27/1982SE |
| K821457 | Hemacount Wrights Stain Pack II #55952IAF · Traditional | Accra Laboratories, Inc. | 06/01/1982SE |
| K820437 | Aves Wright StainIAF · Traditional | Helena Laboratories | 03/26/1982SE |
| K812848 | Accra Lab HemotologyIAF · Traditional | Accra Laboratories, Inc. | 10/23/1981SE |
| K812504 | Accra Lab Wright StainIAF · Traditional | Accra Laboratories, Inc. | 09/23/1981SE |
| K811400 | HemaquikIAF · Traditional | Accra Laboratories, Inc. | 06/18/1981SE |
| K810495 | Stat Stain SetIAF · Traditional | Accra Laboratories, Inc. | 03/17/1981SE |
| K801212 | Wrights Rapid StainIAF · Traditional | Mcb Manufacturing Chemists, Inc. | 05/30/1980SE |
| K792497 | Volu-Sol Statim StainIAF · Traditional | Volu Sol Medical Industries | 12/18/1979SE |
| K792026 | Wrights Rapid StainIAF · Traditional | Mcb Manufacturing Chemists, Inc. | 11/13/1979SE |
| K792017 | Volu-Sol Stat StainIAF · Traditional | Volu Sol Medical Industries | 10/30/1979SE |
| K791929 | Wrights Rapid StainIAF · Traditional | Mcb Manufacturing Chemists, Inc. | 10/11/1979SE |
| K790571 | Quik-StainIAF · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 04/23/1979SE |
| K781587 | Hematology Stain PackIAF · Traditional | Bioscientific | 10/10/1978SE |
| K781384 | Wright Rapid StainIAF · Traditional | Mfg Chemists, Inc. | 08/21/1978SE |
| K781347 | Camco Quik Stain IIIAF · Traditional | Cambridge Chemical Products, Inc. | 08/21/1978SE |
| K770075 | Bio-Dyes Hematology PhosphateIAF · Traditional | Jack W. Kindberg | 03/22/1977SE |
| K770074 | Bio-Dyes Fortified Hematology StainIAF · Traditional | Jack W. Kindberg | 03/22/1977SE |
| K760027 | DSP - Stain PackIAF · Traditional | Harleco | 07/20/1976SE |