510(k) K920220
K920220 is an FDA 510(k) premarket notification submitted by Akers Research Corp. for the device "HEALTHTEST RHEUMATOID FACTOR ASSAY". The FDA issued a decision of Substantially Equivalent on Mar 13, 1992. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Akers Research Corp. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 13, 1992
- Date Received
- Jan 16, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Rheumatoid Factor
- Device Class
- Class II
- Regulation Number
- 866.5775
- Review Panel
- IM
- Submission Type
- 510(k)