510(k) K802974
K802974 is an FDA 510(k) premarket notification submitted by Organon, Inc. for the device "RAPI-DOT". The FDA issued a decision of Substantially Equivalent on December 19, 1980. The device falls under product code JHJ (Agglutination Method, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Organon, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 1980
- Date Received
- November 21, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Agglutination Method, Human Chorionic Gonadotropin
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type