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

Device, Parasite Concentration

21 CFR 866.2900 / Microbiology
FDA source (opens on fda.gov)

LKS is the FDA product code for Device, Parasite Concentration, a class I device type, regulated under 21 CFR 866.2900. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LKS
Device name
Device, Parasite Concentration
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
13
Ingested recalls
0

Clearances, product code LKS

By decision year
13 clearances under product code LKS with a decision year between 1983 and 2006, 1994 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LKS by decision year
YearClearances
19832
19851
19861
19881
19931
19944
19981
20021
20061

Applicants with the most clearances

Product code LKS
Applicants holding the most 510(k) clearances under product code LKS
ApplicantClearances
Para Scientific Co.3
Meridian Diagnostics, Inc.2
Alpha-Tec Systems, Inc.1
Catheter Technology Corp.1
Evergreen Scientific, Inc.1
Hardy Diagnostics1
Medastat Scientific Corp.1
Medical Chemical Corporation1
Sage Products LLC1
Scientific Device Laboratory, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code