510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LYFClass II

Pneumocystis Carinii

21 CFR 866.3780 / Microbiology
FDA source (opens on fda.gov)

LYF is the FDA product code for Pneumocystis Carinii, a class II device type, regulated under 21 CFR 866.3780. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LYF
Device name
Pneumocystis Carinii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
7
Ingested recalls
0

Clearances, product code LYF

By decision year
7 clearances under product code LYF with a decision year between 1988 and 1999, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LYF by decision year
YearClearances
19881
19892
19901
19911
19921
19991

Applicants with the most clearances

Product code LYF
Applicants holding the most 510(k) clearances under product code LYF
ApplicantClearances
Meridian Diagnostics, Inc.2
Chemicon Intl., Inc.1
Dako Corp.1
Disease Detection International, Inc.1
Genetic Systems Corp.1
Polysciences, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code