510(k) K932437
K932437 is an FDA 510(k) premarket notification submitted by J & S Medical Assoc., Inc. for the device "EYE SPOT RF TEST". The FDA issued a decision of Substantially Equivalent on August 23, 1993. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. J & S Medical Assoc., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 1993
- Date Received
- May 19, 1993
- 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