510(k) K780412

TOTAL IRON BINDING CAPACITY by Diagnostic Corp. of America — Product Code JQG

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