Product Code: LKS FDA class 1 21 CFR 866.2900

Device, Parasite Concentration

Microbiology

Device, Parasite Concentration is a laboratory device used to concentrate parasites from stool or other biological specimens, improving the sensitivity of microscopic examination for intestinal parasites such as protozoa and helminths. This device is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is LKS, regulated under 21 CFR 866.2900, within the Microbiology medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: LKS
Device Class: FDA class 1
Regulation Number: 866.2900
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K053257	PARA-PRO FC50	May 12, 2006	Substantially Equivalent	Alpha-Tec Systems, Inc.
K021420	PARACON II/FECAL CONCENTRATOR II	Jun 04, 2002	Substantially Equivalent	Para Scientific Co.
K980077	PARA-PAK SPINCON	Apr 02, 1998	Substantially Equivalent	Meridian Diagnostics, Inc.
K941110	PARAKIT	May 17, 1994	Substantially Equivalent	Hardy Diagnostics
K941129	CON-KIT	May 09, 1994	Substantially Equivalent	Medical Chemical Corp.
K935316	PARASAFE(R) FIXATIVE	Feb 17, 1994	Substantially Equivalent	Scientific Device Laboratory, Inc.
K933370	STOOL TRANSPORT/PROCESSOR	Feb 17, 1994	Substantially Equivalent	Sage Products, Inc.
K931849	PARAPREP	Dec 02, 1993	Substantially Equivalent	Medastat Scientific Corp.
K881649	MODIFIED PARACON(TM) CONCENTRATION KIT	Apr 21, 1988	Substantially Equivalent	Para Scientific Co.
K860034	PARA-PAK MACRO-CON	Feb 21, 1986	Substantially Equivalent	Meridian Diagnostics, Inc.
K853715	PARA CON TM	Oct 02, 1985	Substantially Equivalent	Para Scientific Co.
K833469	FPC FECAL PARASITE CONCENTRATOR	Nov 28, 1983	Substantially Equivalent	Evergreen Scientific, Inc.
K831365	TESTCORP ANA	Jun 02, 1983	Substantially Equivalent	Catheter Technology Corp.