LKS · Device, Parasite Concentration
Microbiology · 21 CFR 866.2900 · Class 1
Overview
| Product Code | LKS |
|---|---|
| Device Name | Device, Parasite Concentration |
| Regulation | 21 CFR 866.2900 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
Classification Rationale
Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K053257 | PARA-PRO FC50 | Alpha-Tec Systems, Inc. | May 12, 2006 | SESE |
| K021420 | PARACON II/FECAL CONCENTRATOR II | Para Scientific Co. | Jun 4, 2002 | SESE |
| K980077 | PARA-PAK SPINCON | Meridian Diagnostics, Inc. | Apr 2, 1998 | SESE |
| K941110 | PARAKIT | Hardy Diagnostics | May 17, 1994 | SESE |
| K941129 | CON-KIT | Medical Chemical Corp. | May 9, 1994 | SESE |
| K935316 | PARASAFE(R) FIXATIVE | Scientific Device Laboratory, Inc. | Feb 17, 1994 | SESE |
| K933370 | STOOL TRANSPORT/PROCESSOR | Sage Products, Inc. | Feb 17, 1994 | SESE |
| K931849 | PARAPREP | Medastat Scientific Corp. | Dec 2, 1993 | SESE |
| K881649 | MODIFIED PARACON(TM) CONCENTRATION KIT | Para Scientific Co. | Apr 21, 1988 | SESE |
| K860034 | PARA-PAK MACRO-CON | Meridian Diagnostics, Inc. | Feb 21, 1986 | SESE |
| K853715 | PARA CON TM | Para Scientific Co. | Oct 2, 1985 | SESE |
| K833469 | FPC FECAL PARASITE CONCENTRATOR | Evergreen Scientific, Inc. | Nov 28, 1983 | SESE |
| K831365 | TESTCORP ANA | Catheter Technology Corp. | Jun 2, 1983 | SESE |
Top Applicants
- Para Scientific Co. — 3 clearances
- Meridian Diagnostics, Inc. — 2 clearances
- Alpha-Tec Systems, Inc. — 1 clearance
- Catheter Technology Corp. — 1 clearance
- Evergreen Scientific, Inc. — 1 clearance
