510(k) K854666
K854666 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530". The FDA issued a decision of Substantially Equivalent on February 5, 1986. The device falls under product code GQI (Antiserum, Cf, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Clinical Sciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1986
- Date Received
- November 21, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Cf, Cytomegalovirus
- Device Class
- Class II
- Regulation Number
- 866.3175
- Review Panel
- MI
- Submission Type