510(k) K920222
K920222 is an FDA 510(k) premarket notification submitted by Akers Research Corp. for the device "HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS". The FDA issued a decision of Substantially Equivalent on Jul 27, 1992. The device falls under product code LJO (Antigen, Iha, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Akers Research Corp. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 27, 1992
- Date Received
- Jan 16, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Iha, Cytomegalovirus
- Device Class
- Class II
- Regulation Number
- 866.3175
- Review Panel
- MI
- Submission Type
- 510(k)