Identity
- Trade Name
- Leica Biosystems Adaptec 8405E Raid Controller FDA UDI
- Generic Name
- Hard-disc-station computer drive FDA UDI
- Device Name
- Leica Biosystems Adaptec 8405E Raid Controller FDA UDI
- Model / Reference
- 23BDI0036 FDA UDI
- Description
- Leica Biosystems Adaptec 8405E Raid Controller FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849832013297 FDA UDI
- 510(k) Number
- K042542 FDA UDI
- FDA Product Code
- JOY FDA UDI
- GMDN Term
- Hard-disc-station computer drive 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Leica Biosystems Adaptec 8405E Raid Controller 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 2d14b10e-dfa1-4dce-b36a-95125a5f6696 38 fields · synced May 30, 2026