Ideia(Tm) Rotavirus
FDA 510(k) K932384 · Dako Diagnostics , Ltd.
510(k) numberK932384
Submission
- Device name
- Ideia(Tm) Rotavirus
- Applicant
- Dako Diagnostics , Ltd.
Cambridgeshire, GB - Received
- May 17, 1993
- Decision date
- December 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIQ – Enzyme Linked Immunoabsorbent Assay, Rotavirus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3405
- Specialty
- Microbiology
Other 510(k)s with product code LIQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990842 | SAS Rota TestLIQ · Traditional | Sa Scientific, Inc. | 08/09/1999SE |
| K972895 | Vidas Rotavirus (RTV) AssayLIQ · Traditional | Biomerieux Vitek, Inc. | 10/03/1997SE |
| K971585 | Immunocard Stat! RotavirusLIQ · Traditional | Meridian Diagnostics, Inc. | 08/20/1997SE |
| K964424 | Rotavirus EiaLIQ · Traditional | Trinity Biotech, Inc. | 08/08/1997SE |
| K965092 | Vidas Rotavirus AssayLIQ · Traditional | Biomerieux Vitek, Inc. | 05/05/1997SE |
| K951208 | Rota-Dan Rapid Rotavirus Eia KitLIQ · Traditional | Eldan Technologies, Ltd. | 02/14/1996SE |
| K942286 | Diarlex Rota-AdenoLIQ · Traditional | Orion Diagnostica, Inc. | 12/14/1994SE |
| K933587 | Immunocard RotavirusLIQ · Traditional | Meridian Diagnostics, Inc. | 02/03/1994SE |
| K915137 | Kallestad Rotavirus MicroplateLIQ · Traditional | Bio-Rad Laboratories, Inc. | 03/04/1992SE |
| K912666 | Dako Elisa Rotavirus Kit- 96 Tests K440LIQ · Traditional | Dako Corp. | 02/14/1992SE |
More from Dako Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K981226 | Imagearainfluenza Virus Group (Types 1,2 and 3) Test and Imagen Parainfluenza Virus Test…GQP · Traditional | 09/28/1998SE |
| K973954 | Imagen Respiratory ScreenGNW · Traditional | 12/22/1997SE |
| K962037 | Imagen Respiratory ScreenGNW · Traditional | 12/26/1996SE |
| K940564 | Ideia(Tm) Chlamydia Blocking Reagents, ModificationLJC · Traditional | 01/11/1996SE |
| K943557 | ImagenGQS · Traditional | 01/09/1995SE |
Questions and answers
When was Ideia(Tm) Rotavirus cleared by the FDA?
Ideia(Tm) Rotavirus (K932384) received a 510(k) decision of Substantially Equivalent on December 27, 1993, 224 days after the submission was received.
What is the product code of K932384?
The FDA product code is LIQ – Enzyme Linked Immunoabsorbent Assay, Rotavirus, a Class I (low risk) device regulated under 21 CFR 866.3405.