Cleared Traditional

HUMAN C5 RID KITS

K942326 · Jay H. Geller · Immunology
Aug 1995
Decision
468d
Days
Class 2
Risk

About This 510(k) Submission

K942326 is an FDA 510(k) clearance for the HUMAN C5 RID KITS, a Complement C5, Antigen, Antiserum, Control (Class II — Special Controls, product code DAY), submitted by Jay H. Geller (Santa Monica, US). The FDA issued a Cleared decision on August 24, 1995, 468 days after receiving the submission on May 13, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K942326 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1994
Decision Date August 24, 1995
Days to Decision 468 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DAY — Complement C5, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240