Name: Predicase
Price: 199 USD

K-number	K133002
Device name	i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials
Applicant	Abbott Point of Care, Inc.
Product code	DHA
Device class	Class II
Decision date	Apr 16, 2015
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.