Rotavirus Latex Agglutination Assay
FDA 510(k) K861172 · Bartels Immunodiagnostic Supplies, Inc.
510(k) numberK861172
Submission
- Device name
- Rotavirus Latex Agglutination Assay
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
Bellevue, WA, US - Received
- March 28, 1986
- Decision date
- July 1, 1986
- 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 |
|---|---|---|
| K864776 | A549 (Human Lung Carcinoma) Culture CellsKIR · Traditional | 12/31/1986SE |
| K860279 | Cytomegalovirus Direct Fluorescent Antibody KitLIN · Traditional | 05/13/1986SE |
| K855034 | American Histo-Id Sys Primary Kit Psa Prostate AntLIJ · Traditional | 03/11/1986SE |
| K842830 | Immunoper-Oxidase Test Kit for Detect ofGQN · Traditional | 11/26/1985SE |
| K852185 | Respiratory Syncytial Virus Direct Fluorescent AntLKT · Traditional | 08/19/1985SE |
| K844105 | Fitc Labeled Chlamydiae Monoclonal Antibody · Traditional | 12/06/1984SE |
| K842834 | HEP-2 CellsKJR · Traditional | 08/28/1984SE |
| K842833 | PMK Primary Monkey Kidney-CellsKJR · Traditional | 08/28/1984SE |
| K842328 | Amer. Histo-Id Sys Primary Lambda ChainDEH · Traditional | 08/03/1984SE |
| K842330 | Amer. Histo-Id Sys Primary Iga 2720-21CZP · Traditional | 08/02/1984SE |
Questions and answers
When was Rotavirus Latex Agglutination Assay cleared by the FDA?
Rotavirus Latex Agglutination Assay (K861172) received a 510(k) decision of Substantially Equivalent on July 1, 1986, 95 days after the submission was received.
What is the product code of K861172?
The FDA product code is LIQ – Enzyme Linked Immunoabsorbent Assay, Rotavirus, a Class I (low risk) device regulated under 21 CFR 866.3405.