Product code LKS
- Device name
- Device, Parasite Concentration
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2900
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K053257 | PARA-PRO FC50 | Alpha-Tec Systems, Inc. | 2006-05-12 |
| K021420 | PARACON II/FECAL CONCENTRATOR II | Para Scientific Co. | 2002-06-04 |
| K980077 | PARA-PAK SPINCON | Meridian Diagnostics, Inc. | 1998-04-02 |
| K941110 | PARAKIT | Hardy Diagnostics | 1994-05-17 |
| K941129 | CON-KIT | Medical Chemical Corp. | 1994-05-09 |
| K933370 | STOOL TRANSPORT/PROCESSOR | Sage Products, Inc. | 1994-02-17 |
| K935316 | PARASAFE(R) FIXATIVE | Scientific Device Laboratory, Inc. | 1994-02-17 |
| K931849 | PARAPREP | Medastat Scientific Corp. | 1993-12-02 |
| K881649 | MODIFIED PARACON(TM) CONCENTRATION KIT | Para Scientific Co. | 1988-04-21 |
| K860034 | PARA-PAK MACRO-CON | Meridian Diagnostics, Inc. | 1986-02-21 |
| K853715 | PARA CON TM | Para Scientific Co. | 1985-10-02 |
| K833469 | FPC FECAL PARASITE CONCENTRATOR | Evergreen Scientific, Inc. | 1983-11-28 |
| K831365 | TESTCORP ANA | Catheter Technology Corp. | 1983-06-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810044208153 | Caplugs/Evergreen | CAPlugs | 2024-05-31 |
| 00810044208160 | Caplugs/Evergreen | CAPlugs | 2024-05-31 |
| 00810044208177 | Caplugs/Evergreen | CAPlugs | 2024-05-31 |
| 00810044208146 | Caplugs/Evergreen | CAPlugs | 2024-05-31 |
| 00816085023656 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-11 |
| 00840733103445 | Para-Pak CON-Trate | MERIDIAN BIOSCIENCE, INC. | 2021-10-27 |
| 00840733102684 | CON-Trate Funnels & Reagent A | MERIDIAN BIOSCIENCE, INC. | 2020-12-10 |
| 00840733102653 | Reagent A (230mL) | MERIDIAN BIOSCIENCE, INC. | 2020-12-09 |
| 00840733102646 | Para-Pak CON-Trate | MERIDIAN BIOSCIENCE, INC. | 2020-12-09 |
| 00840733102639 | Para-Pak SpinCon (No Funnels) | MERIDIAN BIOSCIENCE, INC. | 2020-12-09 |
| 00840733102424 | SpinCon | MERIDIAN BIOSCIENCE, INC. | 2020-12-09 |
| 00840733102394 | SpinCon | MERIDIAN BIOSCIENCE, INC. | 2020-10-26 |
| 00840733102059 | FeKal CON-Trate® Reagent B | MERIDIAN BIOSCIENCE, INC. | 2020-10-26 |
| 00840733102028 | Para-Pak Macro-CON | MERIDIAN BIOSCIENCE, INC. | 2020-10-26 |
| 00840733102721 | Para-Pak CON-Trate | MERIDIAN BIOSCIENCE, INC. | 2020-10-06 |
| 00840733102561 | Para-Pak CON-Trate | MERIDIAN BIOSCIENCE, INC. | 2020-10-06 |
| 00840733102592 | CON-Trate Bulk Tubes & Caps | MERIDIAN BIOSCIENCE, INC. | 2020-09-21 |
| 50885380144934 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-06-28 |
| M445695ASAMPLE1 | PARA-SED | MEDICAL CHEMICAL CORPORATION | 2016-09-20 |
| M445695AEA1 | PARA-SED | MEDICAL CHEMICAL CORPORATION | 2016-09-20 |
| M445695A1 | PARA-SED | MEDICAL CHEMICAL CORPORATION | 2016-09-20 |
| M445694ATUBEFUNNEL1 | MICRO-SED | MEDICAL CHEMICAL CORPORATION | 2016-09-20 |
| M445694ASAMPLE1 | MICRO-SED | MEDICAL CHEMICAL CORPORATION | 2016-09-20 |
| M445694AEA1 | MICRO-SED | MEDICAL CHEMICAL CORPORATION | 2016-09-20 |
| M445694A1 | MICRO-SED | MEDICAL CHEMICAL CORPORATION | 2016-09-20 |
| M445693ASAMPLE1 | SED-CONNECT | MEDICAL CHEMICAL CORPORATION | 2016-09-20 |
| M445693AFUNNEL1 | SED-CONNECT | MEDICAL CHEMICAL CORPORATION | 2016-09-20 |
| M445693AESEDEA50PACK1 | SED-CONNECT | MEDICAL CHEMICAL CORPORATION | 2016-09-20 |
| M445693A50PACK1 | SED-CONNECT | MEDICAL CHEMICAL CORPORATION | 2016-09-20 |