510(k) K852782
K852782 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "HSVI - IGG ELISA-KIT". The FDA issued a decision of Substantially Equivalent on January 21, 1986. The device falls under product code GQO (Antisera, Cf, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Clinical Sciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1986
- Date Received
- July 1, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Cf, Herpesvirus Hominis 1,2
- Device Class
- Class II
- Regulation Number
- 866.3305
- Review Panel
- MI
- Submission Type