510(k) K882822
K882822 is an FDA 510(k) premarket notification submitted by Cyberfluor, Inc. for the device "FIAGEN FERRITIN". The FDA issued a decision of Substantially Equivalent on August 4, 1988. The device falls under product code DFL (Igm, Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Cyberfluor, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1988
- Date Received
- July 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Igm, Ferritin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5550
- Review Panel
- IM
- Submission Type