Cleared Traditional

K800398 - PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT
(FDA 510(k) Clearance)

K800398 · Diagnostica, Inc. · Immunology

Mar 1980

Decision

15d

Days

Class 2

Risk

K800398 is an FDA 510(k) clearance for the PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT. This device is classified as a Igg, Antigen, Antiserum, Control (Class II — Special Controls, product code DEW).

Submitted by Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1980, 15 days after receiving the submission on February 26, 1980.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number	K800398 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 1980
Decision Date	March 12, 1980
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—