Product code LKS— Microbiology

FDA has cleared 13 devices under product code LKS between 1983 and 2006, filed by 10 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20061 clearance
• 20021 clearance
• 19981 clearance
• 19944 clearances
• 19931 clearance
• 19881 clearance
• 19861 clearance
• 19851 clearance
• 19832 clearances

• Para Scientific Co.3 clearances
• Meridian Diagnostics, Inc.2 clearances
• Scientific Device Laboratory, Inc.1 clearance
• Sage Products, Inc.1 clearance
• Medical Chemical Corp.1 clearance
• Medastat Scientific Corp.1 clearance
• Hardy Diagnostics1 clearance
• Evergreen Scientific, Inc.1 clearance
• Catheter Technology Corp.1 clearance
• Alpha-Tec Systems, Inc.1 clearance

• K053257 — PARA-PRO FC50Alpha-Tec Systems, Inc.·2006-05-12
• K021420 — PARACON II/FECAL CONCENTRATOR IIPara Scientific Co.·2002-06-04
• K980077 — PARA-PAK SPINCONMeridian Diagnostics, Inc.·1998-04-02
• K941110 — PARAKITHardy Diagnostics·1994-05-17
• K941129 — CON-KITMedical Chemical Corp.·1994-05-09
• K933370 — STOOL TRANSPORT/PROCESSORSage Products, Inc.·1994-02-17
• K935316 — PARASAFE(R) FIXATIVEScientific Device Laboratory, Inc.·1994-02-17
• K931849 — PARAPREPMedastat Scientific Corp.·1993-12-02
• K881649 — MODIFIED PARACON(TM) CONCENTRATION KITPara Scientific Co.·1988-04-21
• K860034 — PARA-PAK MACRO-CONMeridian Diagnostics, Inc.·1986-02-21
• K853715 — PARA CON TMPara Scientific Co.·1985-10-02
• K833469 — FPC FECAL PARASITE CONCENTRATOREvergreen Scientific, Inc.·1983-11-28
• K831365 — TESTCORP ANACatheter Technology Corp.·1983-06-02