Identity
- Trade Name
- Synermed® FDA UDI
- Generic Name
- Potassium (K+) IVD, reagent FDA UDI
- Device Name
- Potassium Reagent 2 X 66 mL + 1 X 33 mL FDA UDI
- Model / Reference
- VI113-1200 FDA UDI
- Description
- Potassium Reagent 2 X 66 mL + 1 X 33 mL FDA UDI
Identifiers
- Catalog Number
- VI113-1200 FDA UDI
- Primary DI / UDI-DI
- 05060500092009 FDA UDI
- 510(k) Number
- K091455 FDA UDI
- FDA Product Code
- MZV FDA UDI
- GMDN Term
- Potassium (K+) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1600 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
Yes
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+) IVD, reagent
Synermed® by Infrared Laboratory Systems Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Potassium (K+) IVD, reagent.
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- POTASSIUM — STERLING DIAGNOSTICS INC
- Piccolo Electrolyte Panel — ABAXIS, INC. · Class II
- Piccolo MetLyte 8 Panel — ABAXIS, INC. · Class II
- Potassium (K) — Randox Laboratories, Ltd. · Class II
- Piccolo MetLac 12 Panel — ABAXIS, INC. · Class I
Cleared under the same submission
K091455 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 II | Pending data |
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Manufacturer
- Manufacturer
- Infrared Laboratory Systems Llc
Sources (1)
- FDA UDI 628e3778-a841-4539-b9fa-5ecf8ff0d7c1 37 fields · synced Jun 1, 2026