Rotalex Latex Agglutination Test
FDA 510(k) K841319 · Orion Diagnostica, Inc.
510(k) numberK841319
Submission
- Device name
- Rotalex Latex Agglutination Test
- Applicant
- Orion Diagnostica, Inc.
Mchenry, IL, US - Received
- April 2, 1984
- Decision date
- September 14, 1984
- 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 |
More from Bio-Rad Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and…DCK · Traditional | 03/10/2016SE |
| K043125 | Orion Diagnostica Uniq Pinp RiaCIN · Traditional | 05/04/2005SE |
| K042625 | Quikread CRP Calibrator SetJJY · Traditional | 11/18/2004SE |
| K042442 | Quickread System: Quickread CRP Kit, Model 06085; Quickread 101 Instrument, Model 06088…DCK · Special | 09/24/2004SE |
| K942286 | Diarlex Rota-AdenoLIQ · Traditional | 12/14/1994SE |
| K914892 | Saliva-StimEGD · Traditional | 09/02/1992SE |
| K904655 | PylorisetLYR · Traditional | 10/21/1991SE |
| K884147 | Immunochemical Determination of Immunoglobulin MDFT · Traditional | 10/27/1988SE |
| K884074 | Immunochemical Determination of Immunoglobulin GDAH · Traditional | 10/27/1988SE |
| K884075 | Immunochemical Determination of TransferrinDDG · Traditional | 10/19/1988SE |
Questions and answers
When was Rotalex Latex Agglutination Test cleared by the FDA?
Rotalex Latex Agglutination Test (K841319) received a 510(k) decision of Substantially Equivalent on September 14, 1984, 165 days after the submission was received.
What is the product code of K841319?
The FDA product code is LIQ – Enzyme Linked Immunoabsorbent Assay, Rotavirus, a Class I (low risk) device regulated under 21 CFR 866.3405.