Trend Cryptosporidium Detection Test Systems
FDA 510(k) K955755 · Trend Scientific, Inc.
510(k) numberK955755
Submission
- Device name
- Trend Cryptosporidium Detection Test Systems
- Applicant
- Trend Scientific, Inc.
New Brighton, MN, US - Received
- December 20, 1995
- Decision date
- July 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHJ – Cryptosporidium Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3220
- Specialty
- Microbiology
Other 510(k)s with product code MHJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171078 | Tri-Combo Parasite ScreenMHJ · Traditional | Techlab, Inc. | 07/10/2017SE |
| K121565 | Uni-Gold CryptosporidiumMHJ · Traditional | Trinity Biotech | 02/08/2013SE |
| K051929 | Giardia/Cryptosporidium ChekMHJ · Traditional | Techlab, Inc. | 11/17/2005SE |
| K052932 | Cryptosporidium IIMHJ · Special | Techlab, Inc. | 11/04/2005SE |
| K031965 | Xpect Cryptosporidium Lateral Flow Assay, Model 2451020MHJ · Traditional | Remel, Inc. | 11/14/2003SE |
| K031059 | IVD Cryptosporidium Antigen Detection Assay, Model CP-96MHJ · Traditional | Ivd Research, Inc. | 07/10/2003SE |
| K982764 | Premier CryptosporidiumMHJ · Traditional | Meridian Diagnostics, Inc. | 12/03/1998SE |
| K982709 | Modification to Prospect Cryptosporidium Microtiter AssayMHJ · Special | Alexon - Trend, Inc. | 09/03/1998SE |
| K980354 | Cryptosporidium TestMHJ · Traditional | Techlab, Inc. | 05/18/1998SE |
| K955852 | Crypto-Cel If TestMHJ · Traditional | Techlab, Inc. | 08/05/1996SE |
More from Techlab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954996 | Trend Amebiasis (E.Histolytica) Serological Elisa Test SystemKHW · Traditional | 08/08/1996SE |
| K952467 | Trend Giardia Lamblia Direct Detection System (Modified Kit)MHI · Traditional | 11/20/1995SE |
| K953284 | Trend Giardia Direct Detection RS Test SystemMHI · Traditional | 10/06/1995SE |
| K862914 | Fekal Check Parasitology Control SlideJTR · Traditional | 09/16/1986SE |
| K830769 | Fekal Con-Trate SystemKLI · Traditional | 04/05/1983SE |
Questions and answers
When was Trend Cryptosporidium Detection Test Systems cleared by the FDA?
Trend Cryptosporidium Detection Test Systems (K955755) received a 510(k) decision of Substantially Equivalent on July 11, 1996, 204 days after the submission was received.
What is the product code of K955755?
The FDA product code is MHJ – Cryptosporidium Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3220.