Cleared Traditional

VIRGO AMA ELISA KIT

K971909 · Hemagen Diagnostics, Inc. · Immunology

Jun 1997

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K971909 is an FDA 510(k) clearance for the VIRGO AMA ELISA KIT, a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBM), submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on June 20, 1997, 28 days after receiving the submission on May 23, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5090.

Submission Details

510(k) Number	K971909 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 1997
Decision Date	June 20, 1997
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

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