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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
FDA Hosted 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
FDA Hosted 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