510(k) K920753
K920753 is an FDA 510(k) premarket notification submitted by Biowhittaker Molecular Applications, Inc. for the device "RF STAT IGM TEST KIT". The FDA issued a decision of Substantially Equivalent on March 30, 1992. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Biowhittaker Molecular Applications, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 1992
- Date Received
- February 19, 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