Atlas FDA

LKS

13 FDA 510(k) clearances · Product code

61 daysmedian time to decision
223 days90th percentile
13clearances measured

FDA profile

Official device name
Device, Parasite Concentration
Device class
Class I (low risk)
Regulation
21 CFR 866.2900
Medical specialty
Microbiology
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RecordFirmDate
PARA-PRO FC50 (K053257)Alpha-Tec Systems, Inc.2006-05-12
PARACON II/FECAL CONCENTRATOR II (K021420)Para Scientific Co.2002-06-04
PARA-PAK SPINCON (K980077)Meridian Diagnostics, Inc.1998-04-02
PARAKIT (K941110)Hardy Diagnostics1994-05-17
CON-KIT (K941129)Medical Chemical Corp.1994-05-09
STOOL TRANSPORT/PROCESSOR (K933370)Sage Products, Inc.1994-02-17
PARASAFE(R) FIXATIVE (K935316)Scientific Device Laboratory, Inc.1994-02-17
PARAPREP (K931849)Medastat Scientific Corp.1993-12-02
MODIFIED PARACON(TM) CONCENTRATION KIT (K881649)Para Scientific Co.1988-04-21
PARA-PAK MACRO-CON (K860034)Meridian Diagnostics, Inc.1986-02-21
PARA CON TM (K853715)Para Scientific Co.1985-10-02
FPC FECAL PARASITE CONCENTRATOR (K833469)Evergreen Scientific, Inc.1983-11-28
TESTCORP ANA (K831365)Catheter Technology Corp.1983-06-02

Track LKS automatically

Every clearance here is in the API, with alerts when new ones post.