Crypto-Cel If Test
FDA 510(k) K955852 · Techlab, Inc.
510(k) numberK955852
Submission
- Device name
- Crypto-Cel If Test
- Applicant
- Techlab, Inc.
Blacksburg, VA, US - Received
- December 26, 1995
- Decision date
- August 5, 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 |
| K955755 | Trend Cryptosporidium Detection Test SystemsMHJ · Traditional | Trend Scientific, Inc. | 07/11/1996SE |
More from Trend Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K191456 | Campylobacter Quik ChekLQP · Special | 06/20/2019SE |
| K191442 | Campylobacter ChekLQP · Special | 06/20/2019SE |
| K181400 | H. Pylori ChekLYR · Traditional | 08/21/2018SE |
| K181379 | H. Pylori Quik ChekLYR · Traditional | 08/21/2018SE |
| K173219 | Campylobacter ChekLQP · Traditional | 01/22/2018SE |
| K173217 | Campylobacter Quik ChekLQP · Traditional | 01/22/2018SE |
| K171078 | Tri-Combo Parasite ScreenMHJ · Traditional | 07/10/2017SE |
| K170728 | E. Histolytica Quik ChekKHW · Traditional | 06/07/2017SE |
| K082499 | C. Diff Quik Chek CompleteLLH · Traditional | 03/26/2009SE |
| K053572 | C. Diff Quik ChekMCB · Traditional | 04/26/2006SE |
Questions and answers
When was Crypto-Cel If Test cleared by the FDA?
Crypto-Cel If Test (K955852) received a 510(k) decision of Substantially Equivalent on August 5, 1996, 223 days after the submission was received.
What is the product code of K955852?
The FDA product code is MHJ – Cryptosporidium Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3220.