Last synced on 25 January 2026 at 3:41 am

N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000

Page Type
Cleared 510(K)
PDF
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
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