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Cell-Chex Auto
FDA 510(k)FDA UDIClass II (US FDA 510(k))
510(k) K053362
by Streck
Identity
- Trade Name
- Cell-Chex Auto FDA UDI
- Generic Name
- Full blood count IVD, control FDA UDI
- Device Name
- Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 1 vial each of level 1, 2 & 3. FDA UDI
- Model / Reference
- 200066 FDA UDI
- Description
- Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 1 vial each of level 1, 2 & 3. FDA UDI
Identifiers
- Catalog Number
- 200066 FDA UDI
- Primary DI / UDI-DI
- 00844509000594 FDA UDI
- 510(k) Number
- FDA Product Code
- JPK FDA 510(k)FDA UDI
- GMDN Term
- Full blood count IVD, control FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 864.8625 FDA 510(k)
- Regulation Number
- 864.8625 FDA 510(k)FDA UDI
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
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
Dimensions & Sizes
- Size
- Total Volume — 3.0 Milliliter FDA UDI
Cell-Chex Auto by Streck — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
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 | K053362 | Class II | Active |
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Manufacturer
- Manufacturer
- Streck
Sources (2)
- FDA 510(k) K053362 24 fields · synced Jun 18, 2026
- FDA UDI c53e9440-6139-4455-858b-f3d65b3943f4 38 fields · synced May 27, 2026