Panels › Microbiology › Product code GMZ · Class 1
Antigens, All Types, Escherichia Coli
Regulation 866.3255
0510(k)s in 12 months (14 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in GMZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Meridian Bioscience, Inc. | 3 | 0 |
| Techlab Inc., Corporate Research Center | 2 | 0 |
| Alexon - Trend, Inc. | 1 | 0 |
| Guardian Scientific, Corp. | 1 | 0 |
| Hardy Media Inc Dba Hardy Diag | 0 | 1 |
| Inverness Medical-Biostar, Inc. | 1 | 0 |
| Lmd Laboratories | 1 | 0 |
| Medi-Tech, Inc. | 1 | 0 |
| Meridian Diagnostics, Inc. | 1 | 0 |
| Murex Biotech , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 17, 2023 | K222829 | Curian® Shiga Toxin Meridian Bioscience, Inc. | GMZ |
| Oct 2, 2012 | K121411 | SHIGA TOXIN CHEK Techlab Inc., Corporate Research Center | GMZ |
| Oct 2, 2012 | K121364 | SHIGA TOXIN QUIK CHEK Techlab Inc., Corporate Research Center | GMZ |
| Feb 14, 2007 | K062546 | IMMUNOCARD STAT! EHEC, MODEL 751630 Meridian Bioscience, Inc. | GMZ |
| Dec 12, 2006 | K061889 | BIOSTAR OIA SHIGATOX Inverness Medical-Biostar, Inc. | GMZ |
| Jan 3, 2003 | K023599 | IMMUNOCARD STAT! E. COLI O157 PLUS Meridian Bioscience, Inc. | GMZ |
| Aug 9, 1999 | K990263 | IMMUNOCARD STAT! E. COLI O157:H7 Meridian Diagnostics, Inc. | GMZ |
| Apr 23, 1998 | K980507 | PROSPECT SHIGA TOXIN MICROPLATE ASSAY Alexon - Trend, Inc. | GMZ |
| Jan 2, 1998 | K973457 | CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 Shared Systems, Inc. | GMZ |
| Dec 30, 1997 | K971663 | WELLCOLEX E.COLI O157:H7 Murex Biotech , Ltd., GB | GMZ |
| Oct 16, 1997 | K972156 | QUIX RAPID E. COLI O157 STRIP TEST Guardian Scientific, Corp. | GMZ |
| Sep 27, 1995 | K942705 | E. COLI 0157 ELISA STOOL ASSAY Lmd Laboratories | GMZ |
| Dec 15, 1994 | K944421 | E.COLI 0157 LATEX TEST Pro-Lab Diagnostics, CA | GMZ |
| Feb 3, 1989 | K884513 | PF TEST Medi-Tech, Inc. | GMZ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.