Cleared Traditional

RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY

K922801 · Light Diagnostics · Microbiology

Jan 1993

Decision

210d

Days

Class 1

Risk

About This 510(k) Submission

K922801 is an FDA 510(k) clearance for the RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY, a Antisera, Fluorescent, Adenovirus 1-33 (Class I — General Controls, product code GNY), submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on January 6, 1993, 210 days after receiving the submission on June 10, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3020.

Submission Details

510(k) Number	K922801 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 1992
Decision Date	January 06, 1993
Days to Decision	210 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF