Identity
- Trade Name
- Chrono-log FDA UDI
- Generic Name
- Platelet aggregation analyser IVD FDA UDI
- Device Name
- Platelet Aggregometer FDA UDI
- Model / Reference
- 590 FDA UDI
- Description
- Platelet Aggregometer FDA UDI
Identifiers
- Catalog Number
- 590-X FDA UDI
- Primary DI / UDI-DI
- 00811476010376 FDA UDI
- 510(k) Number
- K830749 FDA UDI
- FDA Product Code
- JBX FDA UDI
- GMDN Term
- Platelet aggregation analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.6675 FDA UDI
- 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
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
Category: Platelet aggregation analyser IVD
Chrono-log by Chrono-Log Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Platelet aggregation analyser IVD.
- VerifyNow System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- AggRAM Module (110/220 V) — Helena Laboratories, Corp. · Class II
- AggRAM Analyzer (110V/220V) — Helena Laboratories, Corp. · Class II
- VerifyNow System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- VerifyNow System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- AggRAM Analyzer, Windows 7 (110V/220V) — Helena Laboratories, Corp. · Class II
- VerifyNow System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- VerifyNow System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
Cleared under the same submission
K830749 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chrono-Log Corp
Sources (1)
- FDA UDI cce737fd-4560-4e3a-b39f-5a75ff588dec 36 fields · synced May 31, 2026