Product code HYF
- Device name
- Giemsa Stain
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.1850
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842742 | GIEMSA STAIN | E K Ind., Inc. | 1984-08-15 |
| K833665 | HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK | J.S. Medical Assoc. | 1983-11-25 |
| K833677 | QUICK STAIN WRIGHT'S GIEMSA W/BUFF | J.S. Medical Assoc. | 1983-11-25 |
| K831131 | CASE WRIGHT-GIEMSA STAIN PAK | Case Instruments | 1983-06-08 |
Related GUDID Devices#
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|---|---|---|---|
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| 00630414619248 | Atellica HEMA SMS W-G Stain | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 00630414619255 | Atellica HEMA SMS W-G Buffer | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 00630414323596 | Atellica HEMA SMS W-G Stain | Siemens Healthcare Diagnostics Inc. | 2026-02-06 |
| 04015630971404 | Giemsa Staining Kit | Ventana Medical Systems, Inc. | 2025-12-15 |
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| 10885380152290 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-01-30 |