Cleared Traditional

FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY

K884047 · Disease Detection International, Inc. · Microbiology
Mar 1989
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K884047 is an FDA 510(k) clearance for the FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY, a Pneumocystis Carinii (Class II — Special Controls, product code LYF), submitted by Disease Detection International, Inc. (Irvine, US). The FDA issued a Cleared decision on March 14, 1989, 169 days after receiving the submission on September 26, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K884047 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1988
Decision Date March 14, 1989
Days to Decision 169 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LYF — Pneumocystis Carinii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

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