Cleared Traditional

CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST

K901243 · Cel Labs Pty, Ltd. · Microbiology

May 1990

Decision

67d

Days

Class 1

Risk

About This 510(k) Submission

K901243 is an FDA 510(k) clearance for the CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST, a Antiserum, Fluorescent, Chlamydia Trachomatis (Class I — General Controls, product code LJP), submitted by Cel Labs Pty, Ltd. (Washington, US). The FDA issued a Cleared decision on May 21, 1990, 67 days after receiving the submission on March 15, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number	K901243 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 1990
Decision Date	May 21, 1990
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—