N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000

System, Test, Osteocalcin

OSTEOMETER BIOTECH A/S

The following data is part of a premarket notification filed by Osteometer Biotech A/s with the FDA for N-mid Osteocalcin One Step Elisa Model 30sc4000.

Pre-market Notification Details

Device IDK003609
510k NumberK003609
Device Name:N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
ClassificationSystem, Test, Osteocalcin
Applicant OSTEOMETER BIOTECH A/S HERLEV HOVEDGADE 207 Herlev,  DK Dk-2730
ContactPer Qvist
CorrespondentPer Qvist
OSTEOMETER BIOTECH A/S HERLEV HOVEDGADE 207 Herlev,  DK Dk-2730
Product CodeNEO  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-22
Decision Date2001-05-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060169690516 K003609 000

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