Cleared Traditional

K882623 - PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM
(FDA 510(k) Clearance)

K882623 · Technicon Instruments Corp. · Immunology

Jul 1988

Decision

14d

Days

Class 2

Risk

K882623 is an FDA 510(k) clearance for the PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM. This device is classified as a Factor B, Antigen, Antiserum, Control (Class II — Special Controls, product code JZH).

Submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on July 8, 1988, 14 days after receiving the submission on June 24, 1988.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5320.

Submission Details

510(k) Number	K882623 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 1988
Decision Date	July 08, 1988
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—