Cleared Traditional

HAEMONETICS 600 ML. COMPONENT BAG

K810711 · Haemonetics Corp. · Hematology

May 1981

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K810711 is an FDA 510(k) clearance for the HAEMONETICS 600 ML. COMPONENT BAG, a Container, Empty, For Collection & Processing Of Blood & Blood Components (Class II — Special Controls, product code KSR), submitted by Haemonetics Corp. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1981, 52 days after receiving the submission on March 17, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9100.

Submission Details

510(k) Number	K810711 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 1981
Decision Date	May 08, 1981
Days to Decision	52 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