510(k) K790298
K790298 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "RADIOASSAY, CONTROL SERUM I, II, III". The FDA issued a decision of Substantially Equivalent on April 4, 1979. The device falls under product code DGR (Whole Human Serum, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5700. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1979
- Date Received
- February 12, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Whole Human Serum, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5700
- Review Panel
- HE
- Submission Type