Cleared Traditional

PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT

K890768 · Genetic Systems Corp. · Microbiology
Mar 1989
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K890768 is an FDA 510(k) clearance for the PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT, a Pneumocystis Carinii (Class II — Special Controls, product code LYF), submitted by Genetic Systems Corp. (Seattle, US). The FDA issued a Cleared decision on March 21, 1989, 34 days after receiving the submission on February 15, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K890768 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1989
Decision Date March 21, 1989
Days to Decision 34 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

Similar Devices — LYF Pneumocystis Carinii

LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
K992252 · Chemicon Intl., Inc. · Aug 1999
FUNGI FLUOR KIT
K923349 · Polysciences, Inc. · Oct 1992
STAINING SYSTEM FOR PNEUMOCYSTIS CARINII
K905504 · Dako Corp. · Jun 1991
MERIFLUOR TM PNEUMOCYSTIS MODIFICATION
K904400 · Meridian Diagnostics, Inc. · Oct 1990
FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY
K884047 · Disease Detection International, Inc. · Mar 1989
MERIFLUOR(TM) PNEUMOCYSTIS
K881608 · Meridian Diagnostics, Inc. · Aug 1988