Parakit
FDA 510(k) K941110 · Hardy Diagnostics
510(k) numberK941110
Submission
- Device name
- Parakit
- Applicant
- Hardy Diagnostics
Santa Maria, CA, US - Received
- March 7, 1994
- Decision date
- May 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K853715 | Para Con TMLKS · Traditional | Para Scientific Co. | 10/02/1985SE |
More from Para Scientific Co.
| 510(k) | Device | Decision |
|---|---|---|
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10)JTN · Traditional | 08/20/2026SE |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional | 05/11/2026SE |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30)JTN · Traditional | 11/20/2025SE |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional | 06/26/2025SE |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)JTN · Traditional | 05/15/2025SE |
| K233534 | Viral Transport MediumJSM · Traditional | 08/02/2024SE |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30)JTN · Traditional | 07/18/2024SE |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)JTN · Traditional | 07/06/2023SE |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5)JTN · Traditional | 06/01/2023SE |
| K193504 | HardyDisk AST Cefiderocol 30ug (FDC30)JTN · Traditional | 01/23/2020SE |
Questions and answers
When was Parakit cleared by the FDA?
Parakit (K941110) received a 510(k) decision of Substantially Equivalent on May 17, 1994, 71 days after the submission was received.
What is the product code of K941110?
The FDA product code is LKS – Device, Parasite Concentration, a Class I (low risk) device regulated under 21 CFR 866.2900.