The Wellcome Rotavirus Latex Test ZL40
FDA 510(k) K861634 · Wellcome Diagnostics
510(k) numberK861634
Submission
- Device name
- The Wellcome Rotavirus Latex Test ZL40
- Applicant
- Wellcome Diagnostics
Research Triangle Pk, NC, US - Received
- April 29, 1986
- Decision date
- October 29, 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 |
|---|---|---|
| K915203 | D-Dimer Wellcotest (HA10)DAP · Traditional | 01/31/1992SE |
| K910797 | Streptex Acid Extraction KitGTZ · Traditional | 03/29/1991SE |
| K895461 | Wellcolex Colour Shigella Test ZC51GNB · Traditional | 01/11/1990SE |
| K890146 | Wellcolex Colour Salmonella Test ZL 50GRM · Traditional | 02/16/1989SE |
| K875311 | Wellcozyme HSV WZO2GQN · Traditional | 08/03/1988SE |
| K861628 | Wellcozyme Rotavirus WZ01LIQ · Traditional | 01/21/1987SE |
| K864206 | Reveal Colour Strep a ZL16GTZ · Traditional | 01/13/1987SE |
| K854852 | Wellcogen Bacterial Antigen KitGTJ · Traditional | 02/04/1986SE |
| K854851 | Wellcogen N. Meningitidis B/E. Coli K1 ZL24GTJ · Traditional | 02/04/1986SE |
| K851691 | Willcogen Meningitidis Kit ZL25GTJ · Traditional | 06/10/1985SE |
Questions and answers
When was The Wellcome Rotavirus Latex Test ZL40 cleared by the FDA?
The Wellcome Rotavirus Latex Test ZL40 (K861634) received a 510(k) decision of Substantially Equivalent on October 29, 1986, 183 days after the submission was received.
What is the product code of K861634?
The FDA product code is LIQ – Enzyme Linked Immunoabsorbent Assay, Rotavirus, a Class I (low risk) device regulated under 21 CFR 866.3405.