Product code KIQ
- Device name
- Kit, Culture, Chromosome
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.2260
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K790239 | PHYTOHAEMAGGLUTININ | Pharmacia Fine Chemicals | 1979-03-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
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| 05060174130076 | Metaphase Arresting Solution | GENIAL HELIX LTD | 2023-09-18 |
| 05060174130069 | Chromosome Resolution Additive | GENIAL HELIX LTD | 2023-09-18 |
| 05060174130052 | Bone Marrow Growth Supplement | GENIAL HELIX LTD | 2023-09-18 |
| 05060174130045 | Lymphocyte Growth Supplement | GENIAL HELIX LTD | 2023-09-18 |
| 05060174130038 | Erythrocyte Lysis Solution | GENIAL HELIX LTD | 2023-09-18 |
| 05060174130021 | Anticlotting Reagent | GENIAL HELIX LTD | 2023-09-18 |
| 00857515006306 | Colcemid Solution | FUJIFILM IRVINE SCIENTIFIC, INC. | 2021-04-23 |
| 00893727002484 | Chang Medium in SITU | FUJIFILM IRVINE SCIENTIFIC, INC. | 2021-04-21 |
| 00893727002767 | Chang Medium in SITU | FUJIFILM IRVINE SCIENTIFIC, INC. | 2021-04-21 |
| 00893727002460 | Chang Medium C | FUJIFILM IRVINE SCIENTIFIC, INC. | 2021-04-21 |
| 00893727002453 | Chang Medium C | FUJIFILM IRVINE SCIENTIFIC, INC. | 2021-04-21 |
| 00857515006108 | Chang Medium B | FUJIFILM IRVINE SCIENTIFIC, INC. | 2021-04-20 |
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| 00857515006160 | Chang Medium MF with Gentamicin | FUJIFILM IRVINE SCIENTIFIC, INC. | 2021-04-19 |
| 00893727002774 | Chang Medium D | FUJIFILM IRVINE SCIENTIFIC, INC. | 2021-04-19 |
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| 00893727002477 | Chang Medium D | FUJIFILM IRVINE SCIENTIFIC, INC. | 2021-04-19 |
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