Identity
- Trade Name
- RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor FDA UDI
- Generic Name
- Potassium (K+) electrode IVD FDA UDI
- Device Name
- RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor, for in vitro diagnostics use with Rapidchem® 700, Rapidpoint 350 systems. FDA UDI
- Model / Reference
- 10309082 FDA UDI
- Description
- RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor, for in vitro diagnostics use with Rapidchem® 700, Rapidpoint 350 systems. FDA UDI
Identifiers
- Catalog Number
- 4955798 FDA UDI
- Primary DI / UDI-DI
- 00630414452289 FDA UDI
- 510(k) Number
- K000926 FDA UDI
- FDA Product Code
- CGZ FDA UDICEM FDA UDIJGS FDA UDI
- GMDN Term
- Potassium (K+) electrode IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1170 FDA UDI862.1600 FDA UDI862.1665 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Potassium (K+) electrode IVD
RAPIDChem® 700 RAPIDPoint® 350 K+ Sensor by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Potassium (K+) electrode IVD.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- Potassium Electrode — Medica Corp. · Class II
- Alfa Wassermann — Alfa Wassermann, Inc. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- ISE Potassium Electrode — STANBIO LABORATORY, L.P. · Class II
- I.S.E. K — Randox Laboratories, Ltd. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
Cleared under the same submission
K000926 also covers:
- Chloride Electrode — Medica Corp.
- EasyElectrolyte Reagent Module, Na/K/Cl Analyzers — Medica Corp.
- ISE Chloride Electrode — Medica Corp.
- ISE Cleaning Solution Kit — Medica Corp.
- ISE Disposable Reference Electrode — Medica Corp.
- ISE Potassium Electrode — Medica Corp.
- ISE Reagent Module — Medica Corp.
- ISE Reagent Pack — Medica Corp.
- ISE Sodium electrode — Medica Corp.
- ISE eChloride Electrode — Medica Corp.
- Na/K/Cl Analyzer — Medica Corp.
- RAPIDChem® 700 Chloride Sensor — Siemens Healthcare Diagnostics
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 38d0d833-bcd6-4d37-97df-87b40e705415 37 fields · synced May 30, 2026