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 |