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510(k) K123844

CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST by Chemtron Biotech, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2013
Date Received
December 13, 2012
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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  • K130456 — WUNDER PREGNANCY TEST (April 8, 2014)
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  • K131166 — SOFIA(R) HCG FIA (August 2, 2013)
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