Product code KET
- Device name
- Filters, Cell Collection, Tissue Processing
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.3010
- 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 |
|---|---|---|---|
| K875122 | DISPOSABLE STERILE SYRINGE FILTERS | Corning Medical & Scientific | 1988-01-12 |
| K870196 | PCTE MICROPOROUS MEMBRANE FILTER | Poretics Corp. | 1987-05-12 |
| K844671 | CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON | Corning Medical & Scientific | 1985-02-25 |
| K840556 | DISPOSABLE SYRINGE FILTERS | Corning Medical & Scientific | 1984-03-05 |
| K792633 | STERILIZATION PROCESS/OUTERWRAP | Procter & Gamble Mfg. Co. | 1980-01-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630094188508 | Bioseal Inc. | BIOSEAL | 2023-10-05 |
| 00630094188515 | Bioseal Inc. | BIOSEAL | 2023-10-05 |
| 00630094188607 | Bioseal Inc. | BIOSEAL | 2023-10-05 |
| 00630094887029 | Bioseal Inc. | BIOSEAL | 2023-10-05 |
| 00630094889054 | Bioseal Inc. | BIOSEAL | 2023-10-05 |
| 00810044203899 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044204001 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203905 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203912 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203929 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203936 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203943 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203950 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203967 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203974 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203981 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203998 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203882 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203875 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203868 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203851 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203844 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203837 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203820 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203813 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203806 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203790 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203783 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00810044203776 | Caplugs/Evergreen | CAPlugs | 2021-12-09 |
| 00382904913328 | BD Density Reagent (480 ml) | BECTON, DICKINSON AND COMPANY | 2017-09-08 |