Cleared Traditional

FUNGI FLUOR KIT

K923349 · Polysciences, Inc. · Microbiology

Oct 1992

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K923349 is an FDA 510(k) clearance for the FUNGI FLUOR KIT, a Pneumocystis Carinii (Class II — Special Controls, product code LYF), submitted by Polysciences, Inc. (Warrington, US). The FDA issued a Cleared decision on October 20, 1992, 104 days after receiving the submission on July 8, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number	K923349 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 1992
Decision Date	October 20, 1992
Days to Decision	104 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF