PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS— 510(k) K880031
Substantially EquivalentKallestad Diag, A Div. of Erbamont, Inc.
FDA 510(k) clearance K880031 for PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS, Substantially Equivalent on 1988-03-17. Applicant: Kallestad Diag, A Div. of Erbamont, Inc..
Clearance details
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Product code
- Code LJP
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.