510(k) K904095
K904095 is an FDA 510(k) premarket notification submitted by California Integrated Diagnostics, Inc. for the device "HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING". The FDA issued a decision of Substantially Equivalent on February 1, 1991. The device falls under product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. California Integrated Diagnostics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1991
- Date Received
- September 6, 1990
- 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