510(k) K883684
K883684 is an FDA 510(k) premarket notification submitted by Val Tech Diagnostics, Inc. for the device "HERPES VIRUS CONTROL SLIDES". The FDA issued a decision of Substantially Equivalent on Sep 28, 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. Val Tech Diagnostics, Inc. has 10 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 28, 1988
- Date Received
- Aug 29, 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
- 510(k)