WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM— 510(k) K981750
Substantially EquivalentWieslab AB
FDA 510(k) clearance K981750 for WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM, Substantially Equivalent on 1998-07-22. Applicant: Wieslab AB. Device class: 2.
Clearance details
- Applicant
- Wieslab AB
- Product code
- Code MOB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Frederick, MD, US
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More clearances from Wieslab AB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.