Panels › Microbiology › Product code GNA · Class 1
Antisera, All Types, Escherichia Coli
Regulation 866.3255
0510(k)s in 12 months (12 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in GNA
| Company | 510(k)s | Recalls |
|---|---|---|
| Oxoid , Ltd. | 3 | 0 |
| Meridian Diagnostics, Inc. | 2 | 0 |
| Denka Seiken'S | 1 | 0 |
| Emd Chemicals, Inc. | 1 | 0 |
| Iverness Medical Professional Diagnostics | 1 | 0 |
| Meridian Bioscience Inc | 0 | 1 |
| Murex Diagnostics, Inc. | 1 | 0 |
| Pharmacia, Inc. | 1 | 0 |
| Pro-Lab, Inc. | 1 | 0 |
| Remel Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2007 | K071799 | MODIFICATION TO BIOSTAR OIA SHIGATOX Iverness Medical Professional Diagnostics | GNA |
| Jan 23, 2004 | K031367 | DUOPATH VEROTOXINS GLISA TEST Emd Chemicals, Inc. | GNA |
| Feb 28, 2000 | K993401 | DRYSPOT E.COLI 0157 KIT Oxoid , Ltd., GB | GNA |
| Sep 22, 1998 | K981734 | VTEC-RPLA SEIKEN Denka Seiken'S, JP | GNA |
| Nov 1, 1996 | K962028 | WELLCOLEX E-COLI OI57 ZC60 Murex Diagnostics, Inc. | GNA |
| Nov 14, 1995 | K953362 | PREMIER EHEC Meridian Diagnostics, Inc. | GNA |
| Apr 14, 1995 | K950167 | PREMIER EHEC Meridian Diagnostics, Inc. | GNA |
| Apr 20, 1994 | K933457 | RIM E.COLI 0157:H7 LATEX TEST Remel Co. | GNA |
| Jan 24, 1991 | K903714 | E. COLI 0157 LATEX TEST Pro-Lab, Inc. | GNA |
| Feb 3, 1989 | K884026 | ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT Oxoid U.S.A., Inc. | GNA |
| Sep 2, 1988 | K874288 | PHADEBACT ETEC-LT TEST Pharmacia, Inc. | GNA |
| Nov 4, 1986 | K855234 | DIAGNOSTIC REAGENT VET-RPLA Oxoid U.S.A., Inc. | GNA |
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