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CHRONO-LOG(R) Whole Blood Lumi-Aggregometer
EUDAMEDFDA UDIFDA 510(k)Class A (EU MDR)
Ref 700-2
Identity
- Trade Name
- CHRONO-LOG(R) Whole Blood Lumi-Aggregometer EUDAMEDChrono-log FDA UDI
- Generic Name
- Platelet aggregation analyser IVD FDA UDI
- Device Name
- CHRONO-LOG® Platelet Aggregation Systems EUDAMEDWhole Blood Lumi-Aggregometer FDA UDI
- Model / Reference
- 700-2 EUDAMED700 FDA UDI
- Description
- Whole Blood Lumi-Aggregometer FDA UDI
Identifiers
- Catalog Number
- 700-2 FDA UDI
- Primary DI / UDI-DI
- 00811476010482 EUDAMEDFDA UDI
- Basic UDI-DI
- 081147601AggregometersGT EUDAMED
- 510(k) Number
- K050265 FDA UDI
- FDA Product Code
- JOZ FDA UDI
- EMDN Code
- W0202029099 VARIOUS HEMOSTASIS INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Platelet aggregation analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5700 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
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
No
FDA UDI
CHRONO-LOG(R) Whole Blood Lumi-Aggregometer by Chrono-Log Corp — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K771198 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 081147601AggregometersGT | Class A | Active |
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Manufacturer
- Manufacturer
- Chrono-log Corp
- EUDAMED SRN
- US-MF-000018631
- Authorised Representative
- BioTop Medical NL-AR-000012565
Sources (3)
- EUDAMED be6ce40d-4173-4fb5-ac3d-64b2f041787d 61 fields · synced Jun 19, 2026
- FDA UDI 103b93b3-9d88-476d-8659-de3b320222f9 36 fields · synced May 30, 2026
- FDA 510(k) K771198 1 fields · synced May 18, 2026