510(k) K043031
- Device
- SERIM DIALYSATE MONITOR TEST STRIP
- Applicant
- SERIM RESEARCH CORP.
- 510(k) number
- K043031
- Product code
- NTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-06-13
- Date received
- 2004-11-03
- Regulation
- 876.5820
- Classification name
- Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICIA A RUPCHOCK
- Address
- 23565 Reedy Dr. Elkhart IN US 46514 46514
Source Documents#
Legacy Summary#
summary
FDA Review#
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