510(k) K942908
K942908 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "IGM RF EIA". The FDA issued a decision of Substantially Equivalent on Jan 20, 1995. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 20, 1995
- Date Received
- Jun 21, 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
- 510(k)