Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. Nr. 1203254
FDA 510(k) K023889 · Wiener Laboratories Saic
510(k) numberK023889
Submission
- Device name
- Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. Nr. 1203254
- Applicant
- Wiener Laboratories Saic
Rosario, Santa Fe, AR - Received
- November 21, 2002
- Decision date
- February 11, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MIU – Enzyme Linked Immunosorbent Assay, T. Cruzi
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3870
- Specialty
- Microbiology
Other 510(k)s with product code MIU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161947 | Chagas Detect Plus Rapid TestMIU · Traditional | InBios International, Inc. | 12/16/2016SE |
| K072732 | Ortho T. Cruzi Elisa Test SystemMIU · Traditional | Ortho-Clinical Diagnostics, Inc. | 04/15/2009SE |
| K930272 | Hemagen Chagas' Kit (Eia Method)MIU · Traditional | Hemagen Diagnostics, Inc. | 05/19/1995SE |
| K933716 | Abbott Chagas Antibody EiaMIU · Traditional | Abbott Laboratories | 12/19/1994SE |
| K911233 | Chagas' Igg Elisa TestMIU · Traditional | Gull Laboratories, Inc. | 05/04/1992SE |
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Questions and answers
When was Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. Nr. 1203254 cleared by the FDA?
Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. Nr. 1203254 (K023889) received a 510(k) decision of Substantially Equivalent on February 11, 2004, 447 days after the submission was received.
What is the product code of K023889?
The FDA product code is MIU – Enzyme Linked Immunosorbent Assay, T. Cruzi, a Class I (low risk) device regulated under 21 CFR 866.3870.