Resubmitted Abbott Testpack Rotavirus
FDA 510(k) K880821 · Abbott Laboratories
510(k) numberK880821
Submission
- Device name
- Resubmitted Abbott Testpack Rotavirus
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- March 1, 1988
- Decision date
- May 6, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K932384 | Ideia(Tm) RotavirusLIQ · Traditional | Dako Diagnostics , Ltd. | 12/27/1993SE |
| K915137 | Kallestad Rotavirus MicroplateLIQ · Traditional | Bio-Rad Laboratories, Inc. | 03/04/1992SE |
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Questions and answers
When was Resubmitted Abbott Testpack Rotavirus cleared by the FDA?
Resubmitted Abbott Testpack Rotavirus (K880821) received a 510(k) decision of Substantially Equivalent on May 6, 1988, 66 days after the submission was received.
What is the product code of K880821?
The FDA product code is LIQ – Enzyme Linked Immunoabsorbent Assay, Rotavirus, a Class I (low risk) device regulated under 21 CFR 866.3405.