510(k) K950169
K950169 is an FDA 510(k) premarket notification submitted by Hogan & Hartson for the device "RIBOSOMAL P EIA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on May 23, 1996. The device falls under product code MQA (Anti-Ribosomal P Antibodies), a Class II device regulated under 21 CFR 866.5100. Hogan & Hartson has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1996
- Date Received
- January 17, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Ribosomal P Antibodies
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type