510(k) K941398
K941398 is an FDA 510(k) premarket notification submitted by Theratest Laboratories, Inc. for the device "EL-RF/3 (IGM-IGG-IGA) KIT". The FDA issued a decision of Substantially Equivalent on July 28, 1995. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Theratest Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1995
- Date Received
- March 22, 1994
- 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