Cleared Traditional

i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials

K133002 · Abbott Point of Care, Inc. · Chemistry
Apr 2015
Decision
569d
Days
Class 2
Risk

About This 510(k) Submission

K133002 is an FDA 510(k) clearance for the i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on April 16, 2015, 569 days after receiving the submission on September 24, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K133002 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2013
Decision Date April 16, 2015
Days to Decision 569 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DHA — System, Test, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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