Cleared Traditional

ALPHA PLASMA TRANSFER SET

K820447 · Alpha Therapeutic Corp. · Hematology
Apr 1982
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K820447 is an FDA 510(k) clearance for the ALPHA PLASMA TRANSFER SET, a Set, Transfer (blood/plasma) (Class II — Special Controls, product code KSB), submitted by Alpha Therapeutic Corp. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1982, 55 days after receiving the submission on February 18, 1982. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9875.

Submission Details

510(k) Number K820447 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 1982
Decision Date April 14, 1982
Days to Decision 55 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KSB — Set, Transfer (blood/plasma)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.9875