Wellcolex E-Coli OI57 ZC60
FDA 510(k) K962028 · Murex Diagnostics, Inc.
510(k) numberK962028
Submission
- Device name
- Wellcolex E-Coli OI57 ZC60
- Applicant
- Murex Diagnostics, Inc.
Norcross, GA, US - Received
- May 23, 1996
- Decision date
- November 1, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K903714 | E. Coli 0157 Latex TestGNA · Traditional | Pro-Lab, Inc. | 01/24/1991SE |
| 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 |
|---|---|---|
| K954920 | Murex Rub-ExLQN · Traditional | 08/21/1996SE |
Questions and answers
When was Wellcolex E-Coli OI57 ZC60 cleared by the FDA?
Wellcolex E-Coli OI57 ZC60 (K962028) received a 510(k) decision of Substantially Equivalent on November 1, 1996, 162 days after the submission was received.
What is the product code of K962028?
The FDA product code is GNA – Antisera, All Types, Escherichia Coli, a Class I (low risk) device regulated under 21 CFR 866.3255.