LKS — Device, Parasite Concentration Class I
FDA product code LKS covers "Device, Parasite Concentration", a Class I medical device regulated under 21 CFR 866.2900. Submissions are reviewed by the Microbiology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LKS
- Device Class
- Class I
- Regulation Number
- 866.2900
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K053257 | alpha-tec systems | PARA-PRO FC50 | May 12, 2006 |
| K021420 | para scientific | PARACON II/FECAL CONCENTRATOR II | June 4, 2002 |
| K980077 | meridian diagnostics | PARA-PAK SPINCON | April 2, 1998 |
| K941110 | hardy diagnostics | PARAKIT | May 17, 1994 |
| K941129 | medical chemical | CON-KIT | May 9, 1994 |
| K933370 | sage products | STOOL TRANSPORT/PROCESSOR | February 17, 1994 |
| K935316 | scientific device laboratory | PARASAFE(R) FIXATIVE | February 17, 1994 |
| K931849 | medastat scientific | PARAPREP | December 2, 1993 |
| K881649 | para scientific | MODIFIED PARACON(TM) CONCENTRATION KIT | April 21, 1988 |
| K860034 | meridian diagnostics | PARA-PAK MACRO-CON | February 21, 1986 |
| K853715 | para scientific | PARA CON TM | October 2, 1985 |
| K833469 | evergreen scientific | FPC FECAL PARASITE CONCENTRATOR | November 28, 1983 |
| K831365 | catheter technology | TESTCORP ANA | June 2, 1983 |