Uni-Gold Cryptosporidium
FDA 510(k) K121565 · Trinity Biotech
510(k) numberK121565
Submission
- Device name
- Uni-Gold Cryptosporidium
- Applicant
- Trinity Biotech
Carlsbad, CA, US - Received
- May 29, 2012
- Decision date
- February 8, 2013
- 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 |
| 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 |
| K955755 | Trend Cryptosporidium Detection Test SystemsMHJ · Traditional | Trend Scientific, Inc. | 07/11/1996SE |
More from Trend Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K172254 | Lyme B. burgdorferi (IgM) MarStripe TestLSR · Traditional | 10/23/2017SE |
| K163095 | Lyme B. burgdorferi (IgG) MarStripe TestLSR · Traditional | 02/01/2017SE |
| K120001 | Unigold GiardiaMHI · Traditional | 03/01/2013SE |
| K083896 | Destiny Max Coagulation AnalyzerJPA · Traditional | 07/02/2009SE |
| K033059 | Herpes Group IggLGC · Traditional | 11/26/2003SE |
| K014233 | Captiam Syphilis-G AssayLIP · Special | 01/24/2002SE |
| K011709 | Uni-Gold Strep a Test KitGTZ · Traditional | 11/08/2001SE |
| K001525 | Captia Syphilis-G Elisa Test SystemLIP · Traditional | 11/29/2000SE |
| K991697 | Uni-Gold H. PyloriLYR · Traditional | 12/21/1999SE |
| K982373 | Uni-Gold Strep a Test KitGTY · Traditional | 02/11/1999SE |
Questions and answers
When was Uni-Gold Cryptosporidium cleared by the FDA?
Uni-Gold Cryptosporidium (K121565) received a 510(k) decision of Substantially Equivalent on February 8, 2013, 255 days after the submission was received.
What is the product code of K121565?
The FDA product code is MHJ – Cryptosporidium Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3220.