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ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K092649
510(k) Type
Special
Applicant
ROCHE DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/2010
Days to Decision
160 days
Submission Type
Summary

ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K092649
510(k) Type
Special
Applicant
ROCHE DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/2010
Days to Decision
160 days
Submission Type
Summary