AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT— 510(k) K855034
Substantially EquivalentBartels Immunodiagnostic Supplies, Inc.
FDA 510(k) clearance K855034 for AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT, Substantially Equivalent on 1986-03-11. Applicant: Bartels Immunodiagnostic Supplies, Inc..
Clearance details
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
- Product code
- Code LIJ
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellevue, WA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.