Cleared Traditional

PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT

K020823 · Sanquin Blood Supply Foundation · Immunology

May 2002

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K020823 is an FDA 510(k) clearance for the PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT, a Igg (gamma Chain Specific), Antigen, Antiserum, Control (Class II — Special Controls, product code DFZ), submitted by Sanquin Blood Supply Foundation (Great Neck, US). The FDA issued a Cleared decision on May 14, 2002, 61 days after receiving the submission on March 14, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number	K020823 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2002
Decision Date	May 14, 2002
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF