E. Coli 0157 Latex Test
FDA 510(k) K903714 · Pro-Lab, Inc.
510(k) numberK903714
Submission
- Device name
- E. Coli 0157 Latex Test
- Applicant
- Pro-Lab, Inc.
Round Rock, TX, US - Received
- August 14, 1990
- Decision date
- January 24, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNA – Antisera, All Types, Escherichia Coli
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3255
- Specialty
- Microbiology
Other 510(k)s with product code GNA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071799 | Modification to Biostar Oia ShigatoxGNA · Traditional | Iverness Medical Professional Diagnostics | 10/02/2007SE |
| K031367 | Duopath Verotoxins Glisa TestGNA · Traditional | Emd Chemicals, Inc. | 01/23/2004SE |
| K993401 | Dryspot E.Coli 0157 KitGNA · Traditional | Oxoid , Ltd. | 02/28/2000SE |
| K981734 | Vtec-Rpla SeikenGNA · Traditional | Denka Seiken'S | 09/22/1998SE |
| K962028 | Wellcolex E-Coli OI57 ZC60GNA · Traditional | Murex Diagnostics, Inc. | 11/01/1996SE |
| K953362 | Premier EhecGNA · Traditional | Meridian Diagnostics, Inc. | 11/14/1995SE |
| K950167 | Premier EhecGNA · Traditional | Meridian Diagnostics, Inc. | 04/14/1995SE |
| K933457 | Rim E.Coli 0157:H7 Latex TestGNA · Traditional | Remel Co. | 04/20/1994SE |
| K884026 | Escherichia Coli 0157 Latex Agglutination Test KitGNA · Traditional | Oxoid U.S.A., Inc. | 02/03/1989SE |
| K874288 | Phadebact Etec-Lt TestGNA · Traditional | Pharmacia, Inc. | 09/02/1988SE |
More from Pharmacia, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934383 | Prolex (Streptoccal Grouping Latex Kit)GTZ · Traditional | 01/27/1995SE |
| K914419 | Amniotest(Tm)HIO · Traditional | 09/01/1993SE |
| K921421 | Legionella Reagens for Direct Fluorescent AntibodyLHL · Traditional | 07/28/1992SE |
| K894221 | Rosco PyrrJTO · Traditional | 09/28/1989SE |
| K883996 | X-Act Ldc/IndJSE · Traditional | 10/12/1988SE |
| K883995 | X-Act Urea/TdaJSE · Traditional | 10/12/1988SE |
| K871121 | Protect T.M.JTR · Traditional | 04/14/1987SE |
| K870117 | Neisseria/Branhamella Differential TestJSX · Traditional | 03/20/1987SE |
| K861142 | Master Kit BLRP · Traditional | 07/10/1986SESD |
| K861889 | D'Ala Rapid TestJTO · Traditional | 06/03/1986SE |
Questions and answers
When was E. Coli 0157 Latex Test cleared by the FDA?
E. Coli 0157 Latex Test (K903714) received a 510(k) decision of Substantially Equivalent on January 24, 1991, 163 days after the submission was received.
What is the product code of K903714?
The FDA product code is GNA – Antisera, All Types, Escherichia Coli, a Class I (low risk) device regulated under 21 CFR 866.3255.