The following data is part of a premarket notification filed by Osteometer Biotech A/s with the FDA for Serum Crosslaps One Step Elisa.
Device ID | K990843 |
510k Number | K990843 |
Device Name: | SERUM CROSSLAPS ONE STEP ELISA |
Classification | Column Chromatography & Color Development, Hydroxyproline |
Applicant | OSTEOMETER BIOTECH A/S HERLEV HOVEDGADE 207 Herlev, DK Dk-2730 |
Contact | Per Qvist |
Correspondent | Per Qvist OSTEOMETER BIOTECH A/S HERLEV HOVEDGADE 207 Herlev, DK Dk-2730 |
Product Code | JMM |
CFR Regulation Number | 862.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-15 |
Decision Date | 1999-07-09 |
Summary: | summary |