Data / Medical devices / United States / Kashi Scientific LLC
Kashi Scientific LLC: FDA-registered device maker in Portland, OR, United States, 3 510(k) clearances
Kashi Scientific LLC is registered with the FDA (registration 3020831613) in Portland, OR, United States. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 7, 2016. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3020831613
- Address
- 5020 SW View Point Terr, Portland, OR, United States, 97239
- Owner or operator
- Kashi Scientific LLC (10083194)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- November 1, 2021
- Registered through
- 2026
- Brand names listed
- Blood Collection Set With Pre-Attached Holder, Blood DNA/RNA Extraction Kit, CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL, Conventional Holder - General Type, DNA/RNA Extraction Kit, Disposable Cytology Brush, Disposable Sampling Tube, Gel & Clot Activator Tube and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clinical Sample Concentrator | JJH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Sterile | KDT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Culture Media, Non-Selective And Non-Differential | JSG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Culture Media, Single Biochemical Test | JSF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dropper, Ether | BTP | 1 | Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 7, 2016 | K153388 | IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle | FMI | Substantially Equivalent | Guangzhou Improve Medical Instruments Co., Ltd. | accessdata.fda.gov |
| July 12, 2010 | K093910 | IMPROVACUTER GEL & CLOT ACTIVATOR TUBE | JKA | Substantially Equivalent | Guangzhou Improve Medical Instruments Co., Ltd. | accessdata.fda.gov |
| February 9, 2001 | K003985 | POWDERFREE NITRILE PATIENT EXMINATION GLOVE | LZA | Substantially Equivalent | Guthrie Medicare Products (Melaka) Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Clinical Sample Concentrator
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of System, Blood Collection, Vacuum-Assisted, Manual
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Needle, Hypodermic, Single Lumen
Updated June 7, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.