510(k) K834391
K834391 is an FDA 510(k) premarket notification submitted by Immunostics Co., Inc. for the device "IMMUNO-RA". The FDA issued a decision of Substantially Equivalent on February 3, 1984. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Immunostics Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 1984
- Date Received
- December 14, 1983
- 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