Alpha Plastic Plasma Bottle

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K810897 ↗

FDA Product Code

KSR

Device Class

Class II

Regulation

21 CFR Part 864.9100

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Alpha Therapeutic Corp. →

• What is the Alpha Plastic Plasma Bottle used for?

  The Alpha Plastic Plasma Bottle is used for the collection and processing of blood and blood components in hematology applications.

• Is the Alpha Plastic Plasma Bottle reusable?

  No, the Alpha Plastic Plasma Bottle is supplied as a single-use container.

• What is the regulatory status of the Alpha Plastic Plasma Bottle?

  The device is regulated under FDA 510(k) clearance with a decision description of Substantially Equivalent.

• What type of applications is the Alpha Plastic Plasma Bottle intended for?

  The Alpha Plastic Plasma Bottle is intended for use in hematology applications.