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NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153165
510(k) Type
Special
Applicant
Astute Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/1/2016
Days to Decision
212 days
Submission Type
Summary

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153165
510(k) Type
Special
Applicant
Astute Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/1/2016
Days to Decision
212 days
Submission Type
Summary