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LYF — Pneumocystis Carinii Class II

FDA Device Classification

Classification Details

Product Code
LYF
Device Class
Class II
Regulation Number
866.3780
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K992252chemicon intlLIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965August 10, 1999
K923349polysciencesFUNGI FLUOR KITOctober 20, 1992
K905504dakoSTAINING SYSTEM FOR PNEUMOCYSTIS CARINIIJune 28, 1991
K904400meridian diagnosticsMERIFLUOR TM PNEUMOCYSTIS MODIFICATIONOctober 16, 1990
K890768genetic systemsPNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KITMarch 21, 1989
K884047disease detection internationalFLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAYMarch 14, 1989
K881608meridian diagnosticsMERIFLUOR(TM) PNEUMOCYSTISAugust 4, 1988