510(k) K830623
K830623 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "INDIRECT FLUORO-KIT HSV". The FDA issued a decision of Substantially Equivalent on July 7, 1983. The device falls under product code GQL (Antisera, Fluorescent, 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
- July 7, 1983
- Date Received
- February 28, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, Herpesvirus Hominis 1,2
- Device Class
- Class II
- Regulation Number
- 866.3305
- Review Panel
- MI
- Submission Type