DAT TEST FOR CHAGAS' DISEASE
FDA 510(k) clearance K834328 · decided 1984-03-02
Clearance details
- K-number
- K834328
- Device name
- DAT TEST FOR CHAGAS' DISEASE
- Applicant
- Sero-Immuno Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-09
- Decision date
- 1984-03-02
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- GNE
- Device class
- 1
- Regulation number
- 866.3870
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sero-Immuno Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.