Cleared Traditional

MEDICA IIF-MULTIPLE ANTIBODY TEST KIT

K831100 · Medical Diagnostics, Ca. · Immunology

May 1983

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K831100 is an FDA 510(k) clearance for the MEDICA IIF-MULTIPLE ANTIBODY TEST KIT, a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBM), submitted by Medical Diagnostics, Ca. (Mchenry, US). The FDA issued a Cleared decision on May 4, 1983, 29 days after receiving the submission on April 5, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5090.

Submission Details

510(k) Number	K831100 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 1983
Decision Date	May 04, 1983
Days to Decision	29 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—

Device Classification

Product Code	DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5090