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G5 I HBA1C TEST, G5 II HBA1C TEST

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K041635
510(k) Type
Traditional
Applicant
PROVALIS DIAGNOSTICS LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/16/2004
Days to Decision
61 days
Submission Type
Summary

G5 I HBA1C TEST, G5 II HBA1C TEST

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K041635
510(k) Type
Traditional
Applicant
PROVALIS DIAGNOSTICS LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/16/2004
Days to Decision
61 days
Submission Type
Summary