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510(k) K870117

NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST by Pro-Lab, Inc. — Product Code JSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1987
Date Received
January 12, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Neisseria Gonorrhoeae
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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Other clearances for product code JSX

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