510(k) K875367
K875367 is an FDA 510(k) premarket notification submitted by Enzo Biochem, Inc. for the device "COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV". The FDA issued a decision of Substantially Equivalent on March 28, 1988. The device falls under product code GQM (Antisera, Neutralization, Herpesvirus Hominis), 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
- March 28, 1988
- Date Received
- December 31, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Neutralization, Herpesvirus Hominis
- Device Class
- Class II
- Regulation Number
- 866.3305
- Review Panel
- MI
- Submission Type