Para-Pro FC50
FDA 510(k) K053257 · Alpha-Tec Systems, Inc.
510(k) numberK053257
Submission
- Device name
- Para-Pro FC50
- Applicant
- Alpha-Tec Systems, Inc.
Vancouver, WA, US - Received
- November 22, 2005
- Decision date
- May 12, 2006
- 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 |
|---|---|---|---|
| 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 |
| K853715 | Para Con TMLKS · Traditional | Para Scientific Co. | 10/02/1985SE |
More from Para Scientific Co.
| 510(k) | Device | Decision |
|---|---|---|
| K890861 | Ats Dobell & O'Connor's IodineJTS · Traditional | 03/23/1989SE |
| K890020 | Ats Lugol's Iodine SolutionJTS · Traditional | 02/24/1989SE |
| K890148 | Ats TB Rapid Stain Set Product #034-45ICL · Traditional | 01/24/1989SE |
| K890022 | Ats Mayer's AlbuminKEL · Traditional | 01/10/1989SE |
| K883049 | Ats Para-Set Iodine Alcohol SolutionJTS · Traditional | 08/17/1988SE |
| K883048 | Ats Para-Set Modified Pva Fixative SolutionLDZ · Traditional | 08/17/1988SE |
| K883062 | Ats Schaudinn's Fixative W/Acetic AcidLDW · Traditional | 08/04/1988SE |
| K881949 | Ats Nac-Pac SetJSK · Traditional | 05/25/1988SE |
| K881879 | Ats M/15 Phosphate Buffer, Product #034-42JSK · Traditional | 05/13/1988SE |
| K881698 | Ats Pva Fixative SolutionLDZ · Traditional | 05/13/1988SE |
Questions and answers
When was Para-Pro FC50 cleared by the FDA?
Para-Pro FC50 (K053257) received a 510(k) decision of Substantially Equivalent on May 12, 2006, 171 days after the submission was received.
What is the product code of K053257?
The FDA product code is LKS – Device, Parasite Concentration, a Class I (low risk) device regulated under 21 CFR 866.2900.