510(k) K770866
K770866 is an FDA 510(k) premarket notification submitted by Cedarlake Labs , Ltd. for the device "RABBIT COMPLEMENT". The FDA issued a decision of Substantially Equivalent on June 3, 1977. The device falls under product code DHL (Protein, Complement, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.4100.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1977
- Date Received
- May 11, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protein, Complement, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.4100
- Review Panel
- IM
- Submission Type