FDA Product Code
FDA Product Code MQA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5100
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202540 | EliA Rib-P | Phadia AB | 2021-09-13 | Traditional | PDF ↗ |
| K024151 | EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P | Theratest Laboratories, Inc. | 2003-02-06 | Traditional | PDF ↗ |
| K981237 | QUANTA LITE RIBOSOME P ELISA | Inova Diagnostics, Inc. | 1998-06-05 | Traditional | PDF ↗ |
| K950169 | RIBOSOMAL P EIA TEST SYSTEM | Hogan & Hartson | 1996-05-23 | Traditional | PDF ↗ |
Product code MQA · Class II · Immunology. Data: openFDA.