510(k) K894793
K894793 is an FDA 510(k) premarket notification submitted by Cenogenics Corp. for the device "MONODEX". The FDA issued a decision of Substantially Equivalent on August 21, 1989. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. Cenogenics Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1989
- Date Received
- July 28, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Infectious Mononucleosis
- Device Class
- Class II
- Regulation Number
- 866.5640
- Review Panel
- MI
- Submission Type