Cleared Traditional

ALPHA Y-RECIPIENT SET

K833294 · Alpha Therapeutic Corp. · General Hospital
Dec 1983
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K833294 is an FDA 510(k) clearance for the ALPHA Y-RECIPIENT SET, a Set, Blood Transfusion (Class II — Special Controls, product code BRZ), submitted by Alpha Therapeutic Corp. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983, 95 days after receiving the submission on September 23, 1983. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K833294 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1983
Decision Date December 27, 1983
Days to Decision 95 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code BRZ — Set, Blood Transfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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