510(k) K161947
- Device
- Chagas Detect Plus Rapid Test
- Applicant
- INBIOS INTERNATIONAL, INC.
- 510(k) number
- K161947
- Product code
- MIU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-12-16
- Date received
- 2016-07-14
- Regulation
- 866.3870
- Classification name
- Enzyme Linked Immunosorbent Assay, T. Cruzi
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ESTELA RAYCHAUDHURI
- Address
- 562 1st Ave. S, Suite 600 Seattle WA US 98104 98104
FDA Registration Numbers#
- 3022178699
- 3026565854
- 2250051
- 2029372
- 1319681
- 8040374
- 1181055
- 3032562
- 2431980
- 3043196750
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MIU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072732 | ORTHO T. CRUZI ELISA TEST SYSTEM | Ortho-Clinical Diagnostics, Inc. | 2009-04-15 |
| K023889 | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 | Wiener Laboratories Saic | 2004-02-11 |
| K930272 | HEMAGEN CHAGAS' KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-05-19 |
| K933716 | ABBOTT CHAGAS ANTIBODY EIA | Abbott Laboratories | 1994-12-19 |
| K911233 | CHAGAS' IGG ELISA TEST | Gull Laboratories, Inc. | 1992-05-04 |
Legacy Summary#
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FDA Review#
Decision Summary