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Mission U500 Urine Analyzer
FDA UDIFDA 510(k)Class I (US FDA UDI)
510(k) K111221
Identity
- Trade Name
- MISSION U500 URINE ANALYZER FDA UDI
- Generic Name
- Urine analyser IVD, point-of-care FDA UDI
- Device Name
- URINE ANALYZER with Barcode Reader FDA UDI
- Model / Reference
- U211-111 FDA UDI
- Description
- URINE ANALYZER with Barcode Reader FDA UDI
Identifiers
- Catalog Number
- U211-111 FDA UDI
- Primary DI / UDI-DI
- 20682607200515 FDA UDI
- FDA Product Code
- KQO FDA UDI
- GMDN Term
- Urine analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2900 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
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine analyser IVD, point-of-care
Mission U500 Urine Analyzer by ACON Laboratories, Inc. — Class I — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Urine analyser IVD, point-of-care.
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- Rapid Response — BTNX Inc · Class I
- AIMSTRIP URINE ANALYZER — GERMAINE LABORATORIES, INC. · Class I
- CLINITEK Status® Connector — Siemens Healthcare Diagnostics · Class I
- Rapid Response — BTNX Inc · Class I
- Rapid Response — BTNX Inc · Class I
- My Yodoc — S-CONNECT CO., LTD · Class I
- Rapid Response — BTNX Inc · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111221 | Class I | Active |
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Manufacturer
- Manufacturer
- ACON Laboratories, Inc.
Sources (2)
- FDA UDI df388dd4-ec5c-4013-ba2e-4b3a00d5b03b 60 fields · synced Jun 18, 2026
- FDA 510(k) K111221 1 fields · synced Jun 4, 2026