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 |