510(k) K003609
K003609 is an FDA 510(k) premarket notification submitted by Osteometer Biotech A/S for the device "N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000". The FDA issued a decision of Substantially Equivalent on May 16, 2001. The device falls under product code NEO (System, Test, Osteocalcin), a Class II device regulated under 21 CFR 862.1050. Osteometer Biotech A/S has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2001
- Date Received
- November 22, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Osteocalcin
- Device Class
- Class II
- Regulation Number
- 862.1050
- Review Panel
- CH
- Submission Type