510(k) K811954
K811954 is an FDA 510(k) premarket notification submitted by Immuno Assay Corp. for the device "COMBO-FER IRON DIAGNOSTIC". The FDA issued a decision of Substantially Equivalent on July 27, 1981. The device falls under product code JQG (Radiometric, Fe59, Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Immuno Assay Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1981
- Date Received
- July 8, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiometric, Fe59, Iron Binding Capacity
- Device Class
- Class I
- Regulation Number
- 862.1415
- Review Panel
- CH
- Submission Type