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ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103747
510(k) Type
Traditional
Applicant
ELITECHGROUP SEPPIM S.A.S.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/31/2011
Days to Decision
251 days
Submission Type
Summary

ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103747
510(k) Type
Traditional
Applicant
ELITECHGROUP SEPPIM S.A.S.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/31/2011
Days to Decision
251 days
Submission Type
Summary