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ADAMS A1c HA-8180V, CALIBRATOR 80

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162822
510(k) Type
Traditional
Applicant
Arkray Factory, Inc.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
6/29/2017
Days to Decision
265 days
Submission Type
Summary

ADAMS A1c HA-8180V, CALIBRATOR 80

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162822
510(k) Type
Traditional
Applicant
Arkray Factory, Inc.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
6/29/2017
Days to Decision
265 days
Submission Type
Summary