N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000— 510(k) K003609

Name: FDA 510(k) clearance K003609
Creator: U.S. Food and Drug Administration
Published: 2001-05-16

Substantially Equivalent

Osteometer Biotech A/S

FDA 510(k) clearance K003609 for N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000, Substantially Equivalent on 2001-05-16. Applicant: Osteometer Biotech A/S. Device class: 2.

Clearance details

Applicant: Osteometer Biotech A/S
Product code: Code NEO
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2000-11-22
Decision date: 2001-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herlev, DK

Download summary PDF View on FDA.gov ↗

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