IAF · Wright'S Stain
Hematology · 21 CFR 864.1850 · Class 1
Overview
| Product Code | IAF |
|---|---|
| Device Name | Wright'S Stain |
| Regulation | 21 CFR 864.1850 |
| Device Class | Class 1 |
| Review Panel | Hematology |
| GMP Exempt | Yes |
Identification
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 33)
Showing 20 most recent of 33 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890674 | ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET | Sigma Diagnostics, Inc. | Feb 24, 1989 | SESE |
| K890673 | WRIGHT-GLEMSA STAIN | Sigma Diagnostics, Inc. | Feb 24, 1989 | SESE |
| K854236 | HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS | Nms Pharmaceuticals, Inc. | Oct 10, 1986 | SN |
| K860793 | CAMCO STAIN PAK | Cambridge Chemical Products, Inc. | Mar 18, 1986 | SESE |
| K853241 | HEMATOLOGY STAIN PACK | Fisher Scientific Co., LLC | Aug 19, 1985 | SESE |
| K852138 | WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S | Canyon Diagnostics, Inc. | Jun 13, 1985 | SESE |
| K842744 | WRIGHT STAIN | E K Ind., Inc. | Aug 12, 1984 | SESE |
| K842745 | WRIGHT-GIEMSA QUICK STAIN | E K Ind., Inc. | Aug 10, 1984 | SESE |
| K833678 | HEMATOLOGY WRIGHT'S STAIN PACK | J.S. Medical Assoc. | Nov 25, 1983 | SESE |
| K833260 | STAIN PACK FOR AEROSPRAY SLIDE STAINER | Wescor, Inc. | Oct 28, 1983 | SESE |
| K831605 | HEMATOLOGY PAK | Mercedes Scientific Co., Inc. | Jun 30, 1983 | SESE |
| K830542 | HEMAQUIK II STAINING SOLUTION #55961 | Accra Laboratories, Inc. | Mar 17, 1983 | SESE |
| K830127 | QUIK-DIP BLOOD STAIN | Mercedes Scientific Co., Inc. | Feb 15, 1983 | SESE |
| K822981 | MIDAS 1000 WRIGHT GIEMSA STAIN #66020 | Emd Chemicals, Inc. | Oct 27, 1982 | SESE |
| K822980 | MIDAS 1000 WRIGHT STAIN #66010 | Emd Chemicals, Inc. | Oct 27, 1982 | SESE |
| K821457 | HEMACOUNT WRIGHTS STAIN PACK II #55952 | Accra Laboratories, Inc. | Jun 1, 1982 | SESE |
| K820437 | AVES WRIGHT STAIN | Helena Laboratories | Mar 26, 1982 | SESE |
| K812848 | ACCRA LAB HEMOTOLOGY | Accra Laboratories, Inc. | Oct 23, 1981 | SESE |
| K812504 | ACCRA LAB WRIGHT STAIN | Accra Laboratories, Inc. | Sep 23, 1981 | SESE |
| K811400 | HEMAQUIK | Accra Laboratories, Inc. | Jun 18, 1981 | SESE |
Top Applicants
- Accra Laboratories, Inc. — 6 clearances
- Mcb Manufacturing Chemists, Inc. — 3 clearances
- Cambridge Chemical Products, Inc. — 2 clearances
- E K Ind., Inc. — 2 clearances
- Emd Chemicals, Inc. — 2 clearances
