Vtec-Rpla Seiken
FDA 510(k) K981734 · Denka Seiken'S
510(k) numberK981734
Submission
- Device name
- Vtec-Rpla Seiken
- Applicant
- Denka Seiken'S
Tokyo, JP - Received
- May 18, 1998
- Decision date
- September 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| 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 |
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Questions and answers
When was Vtec-Rpla Seiken cleared by the FDA?
Vtec-Rpla Seiken (K981734) received a 510(k) decision of Substantially Equivalent on September 22, 1998, 127 days after the submission was received.
What is the product code of K981734?
The FDA product code is GNA – Antisera, All Types, Escherichia Coli, a Class I (low risk) device regulated under 21 CFR 866.3255.