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510(k) K091969

EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) by Euroimmun Us, Inc. — Product Code NBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2010
Date Received
July 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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Other clearances for product code NBO

  • K000336 — RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E (June 9, 2000)