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510(k) K991515

INSURE PREGNANCY TEST by Inbios Intl., Inc. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1999
Date Received
April 30, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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