SERIM DIALYSATE MONITOR TEST STRIP
FDA 510(k) clearance K043031 · decided 2005-06-13
Clearance details
- K-number
- K043031
- Device name
- SERIM DIALYSATE MONITOR TEST STRIP
- Applicant
- Serim Research Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-03
- Decision date
- 2005-06-13
- Days to decision
- 222 days
- Clearance type
- Traditional
- Product code
- NTZ
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Elkhart, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.