EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P
FDA 510(k) clearance K024151 · decided 2003-02-06
Clearance details
- K-number
- K024151
- Device name
- EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P
- Applicant
- Theratest Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-06
- Decision date
- 2003-02-06
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- MQA
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Lombard, IL, 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 |
| QUANTA LITE RIBOSOME P ELISA (K981237) | Inova Diagnostics, Inc. | 1998-06-05 |
| RIBOSOMAL P EIA TEST SYSTEM (K950169) | Hogan & Hartson | 1996-05-23 |
Recalls involving this device
No recalls on record reference this clearance.