510(k) K862671
K862671 is an FDA 510(k) premarket notification submitted by Orion Corp. for the device "MICROALBUMINURIA ASSAY". The FDA issued a decision of Substantially Equivalent on September 18, 1986. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Orion Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 1986
- Date Received
- July 14, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Albumin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5040
- Review Panel
- IM
- Submission Type