SERUM CROSSLAPS ONE STEP ELISA

Column Chromatography & Color Development, Hydroxyproline

OSTEOMETER BIOTECH A/S

The following data is part of a premarket notification filed by Osteometer Biotech A/s with the FDA for Serum Crosslaps One Step Elisa.

Pre-market Notification Details

Device IDK990843
510k NumberK990843
Device Name:SERUM CROSSLAPS ONE STEP ELISA
ClassificationColumn Chromatography & Color Development, Hydroxyproline
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 CodeJMM  
CFR Regulation Number862.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-15
Decision Date1999-07-09
Summary:summary

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