510(k) K880679
K880679 is an FDA 510(k) premarket notification submitted by Bion Ent., Ltd. for the device "BION CMV-G TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 3, 1988. The device falls under product code GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Bion Ent., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1988
- Date Received
- February 19, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Cf (Including Cf Control), Cytomegalovirus
- Device Class
- Class II
- Regulation Number
- 866.3175
- Review Panel
- MI
- Submission Type