Identity
- Trade Name
- Na/K/Cl Analyzer FDA UDI
- Generic Name
- Ion-selective analyser IVD FDA UDI
- Device Name
- EasyElectrolyte Na/K/Cl Analyzer FDA UDI
- Model / Reference
- 4002 FDA UDI
- Description
- EasyElectrolyte Na/K/Cl Analyzer FDA UDI
Identifiers
- Catalog Number
- 4002 FDA UDI
- Primary DI / UDI-DI
- 00386100002503 FDA UDI
- 510(k) Number
- K000926 FDA UDI
- FDA Product Code
- JGS FDA UDICEM FDA UDICGZ FDA UDI
- GMDN Term
- Ion-selective analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1665 FDA UDI862.1600 FDA UDI862.1170 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ion-selective analyser IVD
Na/K/Cl Analyzer by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- cobas pro c 503 SBL - DL — Roche Diagnostics Corp. · Class I
- cobas pro Sample Supply Unit — Roche Diagnostics Corp. · Class I
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.
- RAPIDChem® 700 Chloride Sensor — Siemens Healthcare Diagnostics
- RAPIDChem® 700 RAPIDPoint® 340/350 Reference 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA UDI 1c648b91-f2aa-40d1-ac96-b1be0fa51f39 37 fields · synced Jun 8, 2026