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N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K003609
510(k) Type
Traditional
Applicant
OSTEOMETER BIOTECH A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
5/16/2001
Days to Decision
175 days
Submission Type
Summary

N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K003609
510(k) Type
Traditional
Applicant
OSTEOMETER BIOTECH A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
5/16/2001
Days to Decision
175 days
Submission Type
Summary