IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT— 510(k) K971464
Substantially EquivalentEuro-Diagnostica AB
FDA 510(k) clearance K971464 for IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT, Substantially Equivalent on 1997-10-29. Applicant: Euro-Diagnostica AB.
Clearance details
- Applicant
- Euro-Diagnostica AB
- Product code
- Code DBL
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ringoes, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.