510(k) K790380
K790380 is an FDA 510(k) premarket notification submitted by Cederlane Labs , Ltd. for the device "LOW-TOX-H RABBIT COMPLEMENT". The FDA issued a decision of Substantially Equivalent on March 21, 1979. The device falls under product code KTQ (Reagent, Complement), a Class I device regulated under 21 CFR 866.4100.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1979
- Date Received
- February 27, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent, Complement
- Device Class
- Class I
- Regulation Number
- 866.4100
- Review Panel
- IM
- Submission Type