Data / Medical devices / Japan / ASAHI POLYSLIDER COMPANY, LIMITED Okayama-Kuse Plant
ASAHI POLYSLIDER COMPANY, LIMITED Okayama-Kuse Plant: FDA-registered device maker in Maniwa Okayama, Japan, 2 510(k) clearances
ASAHI POLYSLIDER COMPANY, LIMITED Okayama-Kuse Plant is registered with the FDA (registration 8031690) in Maniwa Okayama, Japan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 2, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8031690
- FEI number
- 1000600761
- Address
- 860-2 Misaki, Maniwa Okayama, Japan, 719-3226
- Owner or operator
- ASAHI POLYSLIDER COMPANY, LIMITED (10026630)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 8, 2022
- Registered through
- 2027
- Brand names listed
- Accu-Chek Safe-T-Pro Plus, Accu-Chek Safe-T-Pro Plus Lancing Device, Accu-Chek Softclix, Assure Lance, Assure Lance Plus, Capiject Safety Lancet, HemoCue Safety Lancet, OneTouch Delica Plus Lancets and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 2, 2022 | K222084 | OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie | FMK | Substantially Equivalent | Asahi Polyslider Co., Ltd. | accessdata.fda.gov |
| August 23, 2022 | K221546 | OneTouch Delica Plus Lancing System | QRL | Substantially Equivalent | Asahi Polyslider Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Updated November 2, 2022. 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.