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510(k) K003609

N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 by Osteometer Biotech A/S — Product Code NEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2001
Date Received
November 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Osteocalcin
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

Other clearances by Osteometer Biotech A/S

  • K990843 — SERUM CROSSLAPS ONE STEP ELISA (July 9, 1999)

Other clearances for product code NEO

  • K051297 — ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCH (September 8, 2005)