510(k) K772003
K772003 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "HUMAN REFERENCE SERUM C4 COMPLEMENT". The FDA issued a decision of Substantially Equivalent on Nov 3, 1977. The device falls under product code DAK (Complement C1q, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 3, 1977
- Date Received
- Oct 21, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Complement C1q, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5240
- Review Panel
- IM
- Submission Type
- 510(k)