Cleared Traditional

ALPHA PLASTIC PLASMA BOTTLE

K810897 · Alpha Therapeutic Corp. · Hematology

Sep 1981

Decision

173d

Days

Class 2

Risk

About This 510(k) Submission

K810897 is an FDA 510(k) clearance for the ALPHA PLASTIC PLASMA BOTTLE, a Container, Empty, For Collection & Processing Of Blood & Blood Components (Class II — Special Controls, product code KSR), submitted by Alpha Therapeutic Corp. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981, 173 days after receiving the submission on April 3, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9100.

Submission Details

510(k) Number	K810897 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 1981
Decision Date	September 23, 1981
Days to Decision	173 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—

Device Classification

Product Code	KSR — Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.9100