510(k) K880164
K880164 is an FDA 510(k) premarket notification submitted by Ampcor, Inc. for the device "RF CARD TEST & RF LIQUID TEST". The FDA issued a decision of Substantially Equivalent on February 10, 1988. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Ampcor, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1988
- Date Received
- January 13, 1988
- 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