Product code LYF— Microbiology

FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY

Classification name: Pneumocystis Carinii
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Total cleared: 7
First cleared: 1988-08-04
Most recent: 1999-08-10

Market context for product code LYF

FDA has cleared 7 devices under product code LYF between 1988 and 1999, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19991 clearance
19921 clearance
19911 clearance
19901 clearance
19892 clearances
19881 clearance

Top applicants under product code LYF

Meridian Diagnostics, Inc.2 clearances
Polysciences, Inc.1 clearance
Genetic Systems Corp.1 clearance
Disease Detection International, Inc.1 clearance
Dako Corp.1 clearance
Chemicon Intl., Inc.1 clearance

Recent clearances under product code LYF

K992252 — LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965Chemicon Intl., Inc.·1999-08-10
K923349 — FUNGI FLUOR KITPolysciences, Inc.·1992-10-20
K905504 — STAINING SYSTEM FOR PNEUMOCYSTIS CARINIIDako Corp.·1991-06-28
K904400 — MERIFLUOR TM PNEUMOCYSTIS MODIFICATIONMeridian Diagnostics, Inc.·1990-10-16
K890768 — PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KITGenetic Systems Corp.·1989-03-21
K884047 — FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAYDisease Detection International, Inc.·1989-03-14
K881608 — MERIFLUOR(TM) PNEUMOCYSTISMeridian Diagnostics, Inc.·1988-08-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.