510(k) K771768
K771768 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM". The FDA issued a decision of Substantially Equivalent on Oct 7, 1977. The device falls under product code DEH (Lambda, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 7, 1977
- Date Received
- Sep 19, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Lambda, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5550
- Review Panel
- IM
- Submission Type
- 510(k)