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510(k) K041728

HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE by Immunostics Inc., — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2004
Date Received
June 25, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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