510(k) K780325
K780325 is an FDA 510(k) premarket notification submitted by Icl Scientific for the device "RID SYSTEM-HUMAN C-REACTIVE PROTEIN". The FDA issued a decision of Substantially Equivalent on March 17, 1978. The device falls under product code DEN (Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5420. Icl Scientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1978
- Date Received
- February 27, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5420
- Review Panel
- IM
- Submission Type