Strip, Dialysate Ph Indicator
The Dialysate pH Indicator Strip is a diagnostic strip used to measure and monitor the pH level of dialysate solution in hemodialysis systems, ensuring the solution is within safe parameters for patient treatment. Classified as FDA Class 2 under 21 CFR 876.5820 in the Gastroenterology and Urology specialty, it requires 510(k) premarket notification. The product code is MNV, and it is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- MNV
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K101750 | RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 | Jan 07, 2011 | Substantially Equivalent | Reprocessing Products Corp |
| K031267 | STERICHEK BICARB PH REAGENT STRIPS | Dec 23, 2003 | Substantially Equivalent | Environmental Test Systems, Inc. |
| K936311 | MITEK MINI ANCHOR | Oct 31, 1995 | Substantially Equivalent for Some Indications | Mitek Surgical Products, Inc. |
| K941599 | MITEK ABSORBABLE ANCHOR | Oct 24, 1995 | Substantially Equivalent for Some Indications | Mitek Surgical Products, Inc. |
| K944051 | ABSORBALBE ANCHOR | Aug 02, 1995 | Substantially Equivalent | Mitek Surgical Products, Inc. |
| K945491 | SERIM(TM) BICARB PH REAGENT STRIPS | Feb 01, 1995 | Substantially Equivalent | Serim Research Corp. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.