510(k) K780412
K780412 is an FDA 510(k) premarket notification submitted by Diagnostic Corp. of America for the device "TOTAL IRON BINDING CAPACITY". The FDA issued a decision of Substantially Equivalent on May 26, 1978. The device falls under product code JQG (Radiometric, Fe59, Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415. Diagnostic Corp. of America has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1978
- Date Received
- March 15, 1978
- 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