Chagas' Igg Elisa Test
FDA 510(k) K911233 · Gull Laboratories, Inc.
510(k) numberK911233
Submission
- Device name
- Chagas' Igg Elisa Test
- Applicant
- Gull Laboratories, Inc.
Salt Lake City, UT, US - Received
- March 20, 1991
- Decision date
- May 4, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K023889 | Wiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. Nr. 1203254MIU · Traditional | Wiener Laboratories Saic | 02/11/2004SE |
| 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 |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K983541 | HSV 1+2 Igg Elisa TestLGC · Traditional | 02/26/1999SE |
| K971857 | Mumps Igg Elisa TestyLJY · Traditional | 11/04/1997SE |
| K962343 | Toxo Igg Elisa TestLGD · Traditional | 03/24/1997SE |
| K935730 | Ebna Igg Elisa TestLLM · Traditional | 09/19/1995SE |
| K940093 | Ebv-Ea(D) Igg Elisa TestLSE · Traditional | 09/15/1995SE |
| K941046 | VZV Igg Elisa TestLFY · Traditional | 08/24/1995SE |
| K941198 | Ebv LGG Elisa TestLSE · Traditional | 08/23/1995SE |
| K932333 | Protectoral Ultrasonic Handpiece ProcessorEFB · Traditional | 08/15/1995SE |
| K941624 | Rubella Igg Elisa TestLFX · Traditional | 08/04/1995SE |
| K922759 | HSV-2 Igm Elisa Test--ModificationLGC · Traditional | 10/05/1992SE |
Questions and answers
When was Chagas' Igg Elisa Test cleared by the FDA?
Chagas' Igg Elisa Test (K911233) received a 510(k) decision of Substantially Equivalent on May 4, 1992, 411 days after the submission was received.
What is the product code of K911233?
The FDA product code is MIU – Enzyme Linked Immunosorbent Assay, T. Cruzi, a Class I (low risk) device regulated under 21 CFR 866.3870.