510(k) K890417
K890417 is an FDA 510(k) premarket notification submitted by Atlantic Antibodies for the device "SPQ(TM) ANTIBODY REAGENT SET II FOR C3". The FDA issued a decision of Substantially Equivalent on February 17, 1989. The device falls under product code KTQ (Reagent, Complement), a Class I device regulated under 21 CFR 866.4100. Atlantic Antibodies has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1989
- Date Received
- January 24, 1989
- 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