Cleared Traditional

MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT

K971658 · Jay H. Geller · Immunology

May 1997

Decision

39d

Days

Class 2

Risk

About This 510(k) Submission

K971658 is an FDA 510(k) clearance for the MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT, a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBL), submitted by Jay H. Geller (Santa Monica, US). The FDA issued a Cleared decision on May 23, 1997, 39 days after receiving the submission on April 14, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K971658 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 1997
Decision Date	May 23, 1997
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	DBL — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5660