Identity
- Trade Name
- Iron (Fe) Reagent Kit FDA UDI
- Generic Name
- Iron IVD, kit, spectrophotometry FDA UDI
- Device Name
- Iron Reagent Kit for use with EasyRA Analyzers FDA UDI
- Model / Reference
- 10223-4 FDA UDI
- Description
- Iron Reagent Kit for use with EasyRA Analyzers FDA UDI
Identifiers
- Catalog Number
- 10223-4 FDA UDI
- Primary DI / UDI-DI
- 00386100002190 FDA UDI
- 510(k) Number
- K080810 FDA UDI
- FDA Product Code
- JMO FDA UDI
- GMDN Term
- Iron IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1415 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Iron IVD, kit, spectrophotometry
Iron (Fe) Reagent Kit by Medica Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080810 also covers:
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA UDI 6a58fa4b-c86a-45f2-a4a6-fc6f1972cbf8 37 fields · synced May 30, 2026