510(k) K834328
K834328 is an FDA 510(k) premarket notification submitted by Sero-Immuno Diagnostics, Inc. for the device "DAT TEST FOR CHAGAS' DISEASE". The FDA issued a decision of Substantially Equivalent on March 2, 1984. The device falls under product code GNE (Antigen, Latex Agglutination, T. Cruzi), a Class I device regulated under 21 CFR 866.3870. Sero-Immuno Diagnostics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1984
- Date Received
- December 9, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Latex Agglutination, T. Cruzi
- Device Class
- Class I
- Regulation Number
- 866.3870
- Review Panel
- MI
- Submission Type