Cleared Traditional

K970225 - ALPHA MICRON 20/40 MICROAGGREGATE FILTER
(FDA 510(k) Clearance)

K970225 · Alpha Therapeutic Corp. · General Hospital

Feb 1997

Decision

28d

Days

Class 2

Risk

K970225 is an FDA 510(k) clearance for the ALPHA MICRON 20/40 MICROAGGREGATE FILTER, a Microfilter, Blood Transfusion (Class II — Special Controls, product code CAK), submitted by Alpha Therapeutic Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 14, 1997, 28 days after receiving the submission on January 17, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K970225 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 1997
Decision Date	February 14, 1997
Days to Decision	28 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF