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510(k) K953632

SERIM PYLORITEK TEST KIT by Serim Research Corp. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1995
Date Received
July 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

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