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TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080811
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/20/2008
Days to Decision
88 days
Submission Type
Summary

TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080811
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/20/2008
Days to Decision
88 days
Submission Type
Summary