IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES— 510(k) K962360
Substantially EquivalentScimedx Corp.
FDA 510(k) clearance K962360 for IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES, Substantially Equivalent on 1996-09-30. Applicant: Scimedx Corp.. Device class: 2.
Clearance details
- Applicant
- Scimedx Corp.
- 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
- Denvill, NJ, US
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More clearances from Scimedx Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.