Identity
- Trade Name
- PENTRA C400 STD FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
- Device Name
- PENTRA C400 STD (110V) FDA UDI
- Model / Reference
- 1300018784 FDA UDI
- Description
- PENTRA C400 STD (110V) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230006740 FDA UDI
- 510(k) Number
- K052007 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple clinical chemistry analyser IVD, laboratory
Pentra C400 Std by Horiba Abx — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K052007 also covers:
- ABX PENTRA 400 ISE — Horiba Abx
- ABX PENTRA 400 ISE — Horiba Abx
- ABX PENTRA 400 ISE — Horiba Abx
- ABX PENTRA 400 STD — Horiba Abx
- ABX PENTRA 400 STD — Horiba Abx
- ABX PENTRA CHLORIDE-E — Horiba Abx
- ABX PENTRA POTASSIUM-E — Horiba Abx
- ABX PENTRA REFERENCE — Horiba Abx
- ABX PENTRA REFERENCE 280ML — Horiba Abx
- ABX PENTRA REFERENCE-E — Horiba Abx
- ABX PENTRA SODIUM-E — Horiba Abx
- ABX PENTRA STANDARD 1 — Horiba Abx
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 |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (1)
- FDA UDI 88ec71b8-38c0-4c9f-bbf2-aaf6d0d291c8 34 fields · synced Jun 6, 2026