RENALYZER PRX 90
FDA 510(k) clearance K903034 · decided 1991-03-13
Clearance details
- K-number
- K903034
- Device name
- RENALYZER PRX 90
- Applicant
- Swedish Trade Council USA
- Decision
- Substantially Equivalent
- Date received
- 1990-07-11
- Decision date
- 1991-03-13
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- CGL
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| ABL8X7 FLEX (K051968) | Radiometer Medical Aps | 2006-10-16 |
| STAT PROFILE M7 ANALYZER (K991727) | Nova Biomedical Corp. | 1999-07-16 |
| I-STAT SYSTEM (K973292) | I-Stat Corp. | 1997-10-20 |
Recalls involving this device
No recalls on record reference this clearance.