510(k) K812056
K812056 is an FDA 510(k) premarket notification submitted by Ramco Laboratories, Inc. for the device "SPECTRO FEIRITIN". The FDA issued a decision of Substantially Equivalent on August 12, 1981. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Ramco Laboratories, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1981
- Date Received
- July 21, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ferritin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5340
- Review Panel
- IM
- Submission Type