MHJ — Cryptosporidium Spp. Class II
FDA product code MHJ covers "Cryptosporidium Spp.", a Class II medical device regulated under 21 CFR 866.3220. Submissions are reviewed by the Microbiology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MHJ
- Device Class
- Class II
- Regulation Number
- 866.3220
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K171078 | techlab | TRI-COMBO PARASITE SCREEN | July 10, 2017 |
| K121565 | trinity biotech | UNI-GOLD CRYPTOSPORIDIUM | February 8, 2013 |
| K051929 | techlab | GIARDIA/CRYPTOSPORIDIUM CHEK | November 17, 2005 |
| K052932 | techlab | CRYPTOSPORIDIUM II | November 4, 2005 |
| K031965 | remel | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 | November 14, 2003 |
| K031059 | ivd research | IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 | July 10, 2003 |
| K982764 | meridian diagnostics | PREMIER CRYPTOSPORIDIUM | December 3, 1998 |
| K982709 | alexon - trend | MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY | September 3, 1998 |
| K980354 | techlab | CRYPTOSPORIDIUM TEST | May 18, 1998 |
| K955852 | techlab | CRYPTO-CEL IF TEST | August 5, 1996 |
| K955755 | trend scientific | TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS | July 11, 1996 |
| K955345 | lmd laboratories | LMD CRYPTOSPORIDIUM ANTIGEN DETECTION | June 7, 1996 |
| K936191 | alexon biomedical | PROSPECT CRYPTOSPORIDIUM RAPID ASSAY | November 17, 1994 |
| K912242 | alexon | PROSPECT(TM/CRYPTOSPORIDIUM | March 23, 1992 |
| K905598 | lmd laboratories | CRYPTOSPORIDIUM ANTIGEN DETECTION | September 5, 1991 |