510(k) K031367
- Device
- DUOPATH VEROTOXINS GLISA TEST
- Applicant
- Emd Chemicals, Inc.
- 510(k) number
- K031367
- Product code
- GNA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-01-23
- Date received
- 2003-04-30
- Regulation
- 866.3255
- Classification name
- Antisera, All Types, Escherichia Coli
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- ANNA G BENTLEY
- Address
- 480 S. Democrat Rd. Gibbstown NJ US 08027 08027
FDA Registration Numbers#
- 9611882
- 1119779
- 8020667
- 1025402
- 8010096
- 3008987086
- 3038206980
- 1524213
- 8010383
- 3043127699
- 1924669
- 3003750284
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GNA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K071799 | MODIFICATION TO BIOSTAR OIA SHIGATOX | Iverness Medical Professional Diagnostics | 2007-10-02 |
| K993401 | DRYSPOT E.COLI 0157 KIT | Oxoid , Ltd. | 2000-02-28 |
| K981734 | VTEC-RPLA SEIKEN | Denka Seiken'S | 1998-09-22 |
| K962028 | WELLCOLEX E-COLI OI57 ZC60 | Murex Diagnostics, Inc. | 1996-11-01 |
| K953362 | PREMIER EHEC | Meridian Diagnostics, Inc. | 1995-11-14 |
| K950167 | PREMIER EHEC | Meridian Diagnostics, Inc. | 1995-04-14 |
| K933457 | RIM E.COLI 0157:H7 LATEX TEST | Remel Co. | 1994-04-20 |
| K903714 | E. COLI 0157 LATEX TEST | Pro-Lab, Inc. | 1991-01-24 |
| K884026 | ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT | Oxoid U.S.A., Inc. | 1989-02-03 |
| K874288 | PHADEBACT ETEC-LT TEST | Pharmacia, Inc. | 1988-09-02 |
| K855234 | DIAGNOSTIC REAGENT VET-RPLA | Oxoid U.S.A., Inc. | 1986-11-04 |