RIBOSOMAL P EIA TEST SYSTEM
FDA 510(k) clearance K950169 · decided 1996-05-23
Clearance details
- K-number
- K950169
- Device name
- RIBOSOMAL P EIA TEST SYSTEM
- Applicant
- Hogan & Hartson
- Decision
- Substantially Equivalent
- Date received
- 1995-01-17
- Decision date
- 1996-05-23
- Days to decision
- 492 days
- Clearance type
- Traditional
- Product code
- MQA
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Washington, D.C., DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EliA Rib-P (K202540) | Phadia AB | 2021-09-13 |
| EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P (K024151) | Theratest Laboratories, Inc. | 2003-02-06 |
| QUANTA LITE RIBOSOME P ELISA (K981237) | Inova Diagnostics, Inc. | 1998-06-05 |
Recalls involving this device
No recalls on record reference this clearance.