The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Ribosomal P Eia Test System.
| Device ID | K950169 |
| 510k Number | K950169 |
| Device Name: | RIBOSOMAL P EIA TEST SYSTEM |
| Classification | Anti-ribosomal P Antibodies |
| Applicant | HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Contact | Edward C Wilson, Jr. |
| Correspondent | Edward C Wilson, Jr. HOGAN & HARTSON COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Product Code | MQA |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-17 |
| Decision Date | 1996-05-23 |
| Summary: | summary |