510(k) K834328
- Device
- DAT TEST FOR CHAGAS' DISEASE
- Applicant
- SERO-IMMUNO DIAGNOSTICS, INC.
- 510(k) number
- K834328
- Product code
- GNE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-03-02
- Date received
- 1983-12-09
- Regulation
- 866.3870
- Classification name
- Antigen, Latex Agglutination, T. Cruzi
- Medical specialty
- Microbiology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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