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MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K012286
510(k) Type
Special
Applicant
ROCHE DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/8/2001
Days to Decision
19 days
Submission Type
Summary

MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K012286
510(k) Type
Special
Applicant
ROCHE DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/8/2001
Days to Decision
19 days
Submission Type
Summary