ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY— 510(k) K954831
Substantially EquivalentOrgentec
FDA 510(k) clearance K954831 for ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY, Substantially Equivalent on 1996-05-08. Applicant: Orgentec. Device class: 2.
Clearance details
- Applicant
- Orgentec
- Product code
- Code LKO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Windham, NH, US
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More clearances from Orgentec
view allData sourced from openFDA. This site is unofficial and independent of the FDA.