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510(k) K000336

RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E by Rhigene, Inc. — Product Code NBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2000
Date Received
February 3, 2000
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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