FDA 510(k) Applications Submitted by PAUL VANDERWERF

FDA 510(k) Number Submission Date Device Name Applicant
K001154 04/10/2000 I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER I-STAT CORP.
K001387 05/02/2000 I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 I-STAT CORP.
K011478 05/14/2001 I-STAT SYSTEM I-STAT CORP.
K992571 08/02/1999 I-STAT SYSTEM I-STAT CORP.
K012478 08/02/2001 MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER I-STAT CORP.
K023582 10/24/2002 I-STAT KAOLIN ACT TEST I-STAT CORPORATION
K053110 11/04/2005 I-STAT CHEM8 + CARTRIDGE I-STAT CORPORATION


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