Cleared Traditional

HAEMONETICS 1000ML COMPONENT BAG

K811449 · Haemonetics Corp. · Hematology

Jul 1981

Decision

40d

Days

Class 2

Risk

About This 510(k) Submission

K811449 is an FDA 510(k) clearance for the HAEMONETICS 1000ML COMPONENT BAG, a Container, Empty, For Collection & Processing Of Blood & Blood Components (Class II — Special Controls, product code KSR), submitted by Haemonetics Corp. (Walker, US). The FDA issued a Cleared decision on July 1, 1981, 40 days after receiving the submission on May 22, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9100.

Submission Details

510(k) Number	K811449 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 1981
Decision Date	July 01, 1981
Days to Decision	40 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