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510(k) K003856

EZ-HCG URINE(PREGNANCY TEST) by Biomerica, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2001
Date Received
December 13, 2000
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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  • K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (July 17, 2012)