Cleared Traditional

STAT-20 FLUOROMETER

K882677 · Weaver Medical · Immunology

Jul 1988

Decision

14d

Days

Class 1

Risk

About This 510(k) Submission

K882677 is an FDA 510(k) clearance for the STAT-20 FLUOROMETER, a Fluorometer (Class I — General Controls, product code JZT), submitted by Weaver Medical (Salt Lake City, US). The FDA issued a Cleared decision on July 12, 1988, 14 days after receiving the submission on June 28, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 866.4520.

Submission Details

510(k) Number	K882677 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 1988
Decision Date	July 12, 1988
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—