Identity
- Trade Name
- Leica Biosystems DELL 7910 CV Ultimate Service PC FDA UDI
- Generic Name
- Desktop computer FDA UDI
- Device Name
- Leica Biosystems DELL 7910 CV Ultimate Service PC FDA UDI
- Model / Reference
- 23CPU7910ULT_SPARE FDA UDI
- Description
- Leica Biosystems DELL 7910 CV Ultimate Service PC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849832010920 FDA UDI
- 510(k) Number
- K042542 FDA UDI
- FDA Product Code
- JOY FDA UDI
- GMDN Term
- Desktop computer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5260 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Leica Biosystems DELL 7910 CV Ultimate Service PC by Leica Biosystems Richmond, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K042542 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
- Leica Biosystems Richmond, Inc.
Sources (1)
- FDA UDI 95d15449-ec98-478b-9ead-bc78f841b1d1 38 fields · synced May 30, 2026