Product code KQC
- Device name
- Stains, Hematology
- 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 |
|---|---|---|---|
| K882873 | FIELDTEX HEMATOXYLIN | Anatech, Ltd. | 1988-07-28 |
| K852843 | GENERAL DIAGNOSTICS COAG-A-MATE XC | Warner-Lambert Co. | 1985-08-13 |
| K843619 | RETIC-SET | R&D Systems, Inc. | 1984-10-30 |
| K841848 | RETIC-SET | R&D Systems, Inc. | 1984-05-31 |
| K792550 | PONCEAU S STAIN SET | Electrophoresis Corp. of America | 1980-01-16 |
| K792496 | VOLU-SOL NMB RETICULOCYTE STAIN | Volu Sol Medical Industries | 1979-12-31 |
| K791007 | STAT DIFF STAIN | Bioscientific | 1979-08-03 |
| K760485 | HEMASTAIN FIXATIVE | Geometric Data, Div. Smithkline Corp. | 1976-08-30 |
| K760487 | HEMASTAIN PHOSPHATE BUFFER | Geometric Data, Div. Smithkline Corp. | 1976-08-30 |
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|---|---|---|---|
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| 00817169024767 | 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | 2022-12-29 |
| 10664369201385 | STROMATOLYSER-4DS | SYSMEX CORPORATION | 2022-11-04 |
| 80664369201384 | STROMATOLYSER-4DS | SYSMEX CORPORATION | 2022-11-04 |
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