Cleared Traditional

HAEMONETICS 1400 ML THERAPEUTIC BAG

K810313 · Haemonetics Corp. · Hematology

Mar 1981

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K810313 is an FDA 510(k) clearance for the HAEMONETICS 1400 ML THERAPEUTIC 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 March 31, 1981, 54 days after receiving the submission on February 5, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9100.

Submission Details

510(k) Number	K810313 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 1981
Decision Date	March 31, 1981
Days to Decision	54 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