510(k) K881345
K881345 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "IMX FERRITIN". The FDA issued a decision of Substantially Equivalent on May 11, 1988. The device falls under product code DGD (Igg, Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 1988
- Date Received
- March 30, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Igg, Ferritin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type