Panels › Microbiology › Product code MHJ · Class 2
Cryptosporidium Spp.
Regulation 866.3220
0510(k)s in 12 months (15 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MHJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Techlab, Inc. | 5 | 0 |
| Lmd Laboratories | 2 | 0 |
| Remel, Inc. | 1 | 1 |
| Alexon, Inc. | 1 | 0 |
| Alexon Biomedical, Inc. | 1 | 0 |
| Alexon - Trend, Inc. | 1 | 0 |
| Ivd Research, Inc. | 1 | 0 |
| Meridian Diagnostics, Inc. | 1 | 0 |
| Trend Scientific, Inc. | 1 | 0 |
| Trinity Biotech | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 2017 | K171078 | TRI-COMBO PARASITE SCREEN Techlab, Inc. | MHJ |
| Feb 8, 2013 | K121565 | UNI-GOLD CRYPTOSPORIDIUM Trinity Biotech | MHJ |
| Nov 17, 2005 | K051929 | GIARDIA/CRYPTOSPORIDIUM CHEK Techlab, Inc. | MHJ |
| Nov 4, 2005 | K052932 | CRYPTOSPORIDIUM II Techlab, Inc. | MHJ |
| Nov 14, 2003 | K031965 | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 Remel, Inc. | MHJ |
| Jul 10, 2003 | K031059 | IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 Ivd Research, Inc. | MHJ |
| Dec 3, 1998 | K982764 | PREMIER CRYPTOSPORIDIUM Meridian Diagnostics, Inc. | MHJ |
| Sep 3, 1998 | K982709 | MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY Alexon - Trend, Inc. | MHJ |
| May 18, 1998 | K980354 | CRYPTOSPORIDIUM TEST Techlab, Inc. | MHJ |
| Aug 5, 1996 | K955852 | CRYPTO-CEL IF TEST Techlab, Inc. | MHJ |
| Jul 11, 1996 | K955755 | TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS Trend Scientific, Inc. | MHJ |
| Jun 7, 1996 | K955345 | LMD CRYPTOSPORIDIUM ANTIGEN DETECTION Lmd Laboratories | MHJ |
| Nov 17, 1994 | K936191 | PROSPECT CRYPTOSPORIDIUM RAPID ASSAY Alexon Biomedical, Inc. | MHJ |
| Mar 23, 1992 | K912242 | PROSPECT(TM/CRYPTOSPORIDIUM Alexon, Inc. | MHJ |
| Sep 5, 1991 | K905598 | CRYPTOSPORIDIUM ANTIGEN DETECTION Lmd Laboratories | MHJ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.