510(k) K880604
K880604 is an FDA 510(k) premarket notification submitted by Enzo Biochem, Inc. for the device "COLORGENE HSV DNA HYBRIDIZATION TEST". The FDA issued a decision of Substantially Equivalent on August 3, 1988. The device falls under product code GQN (Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Enzo Biochem, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1988
- Date Received
- February 12, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- Device Class
- Class II
- Regulation Number
- 866.3305
- Review Panel
- MI
- Submission Type