510(k) K982041
K982041 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "UIBC". The FDA issued a decision of Substantially Equivalent on Jul 30, 1998. The device falls under product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Abbott Laboratories has 889 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 30, 1998
- Date Received
- Jun 10, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Ferrozine (Colorimetric) Iron Binding Capacity
- Device Class
- Class I
- Regulation Number
- 862.1415
- Review Panel
- CH
- Submission Type
- 510(k) Exempt