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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: CGA Applicant: I-STAT CORP. Decision Date To: 01/29/2023
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i-stat system I-STAT CORP. K011478 07/02/2001
i-stat portable clinical analyzer, model 300 I-STAT CORP. K001387 10/05/2000
i-stat model 200 portable clinical analyzer I-STAT CORP. K001154 04/18/2000
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