Para Con TM
FDA 510(k) K853715 · Para Scientific Co.
510(k) numberK853715
Submission
- Device name
- Para Con TM
- Applicant
- Para Scientific Co.
Lake Oswego, OR, US - Received
- September 4, 1985
- Decision date
- October 2, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKS – Device, Parasite Concentration
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
Other 510(k)s with product code LKS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053257 | Para-Pro FC50LKS · Traditional | Alpha-Tec Systems, Inc. | 05/12/2006SE |
| K021420 | Paracon Ii/Fecal Concentrator IILKS · Traditional | Para Scientific Co. | 06/04/2002SE |
| K980077 | Para-Pak SpinconLKS · Traditional | Meridian Diagnostics, Inc. | 04/02/1998SE |
| K941110 | ParakitLKS · Traditional | Hardy Diagnostics | 05/17/1994SE |
| K941129 | Con-KitLKS · Traditional | Medical Chemical Corp. | 05/09/1994SE |
| K935316 | Parasafe(R) FixativeLKS · Traditional | Scientific Device Laboratory, Inc. | 02/17/1994SE |
| K933370 | Stool Transport/ProcessorLKS · Traditional | Sage Products, Inc. | 02/17/1994SE |
| K931849 | ParaprepLKS · Traditional | Medastat Scientific Corp. | 12/02/1993SE |
| K881649 | Modified Paracon(Tm) Concentration KitLKS · Traditional | Para Scientific Co. | 04/21/1988SE |
| K860034 | Para-Pak Macro-ConLKS · Traditional | Meridian Diagnostics, Inc. | 02/21/1986SE |
More from Meridian Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021420 | Paracon Ii/Fecal Concentrator IILKS · Traditional | 06/04/2002SE |
| K964144 | Paracon Plus Formalin - Pcp-F, Paracon Plus Saf - Pcp-Saf and Paracon Plus MF - Pcp-MfLIO · Traditional | 11/27/1996SE |
| K881649 | Modified Paracon(Tm) Concentration KitLKS · Traditional | 04/21/1988SE |
| K872751 | Fluortran - C(Tm)LIO · Traditional | 07/23/1987SE |
Questions and answers
When was Para Con TM cleared by the FDA?
Para Con TM (K853715) received a 510(k) decision of Substantially Equivalent on October 2, 1985, 28 days after the submission was received.
What is the product code of K853715?
The FDA product code is LKS – Device, Parasite Concentration, a Class I (low risk) device regulated under 21 CFR 866.2900.