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.
| Device ID | K003609 |
| 510k Number | K003609 |
| Device Name: | N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 |
| Classification | System, Test, Osteocalcin |
| 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 | NEO |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-22 |
| Decision Date | 2001-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060169690516 | K003609 | 000 |