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510(k) K133002

i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials by Abbott Point of Care, Inc. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2015
Date Received
September 24, 2013
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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