DIALYSIS CONCENTRATE
FDA 510(k) clearance K851319 · decided 1985-07-02
Clearance details
- K-number
- K851319
- Device name
- DIALYSIS CONCENTRATE
- Applicant
- Ries Biologicals
- Decision
- Substantially Equivalent
- Date received
- 1985-04-02
- Decision date
- 1985-07-02
- Days to decision
- 91 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.