510(k) K905608
K905608 is an FDA 510(k) premarket notification submitted by Stellar Bio Systems, Inc. for the device "INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1". The FDA issued a decision of Substantially Equivalent on November 7, 1991. The device falls under product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Stellar Bio Systems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1991
- Date Received
- December 14, 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