Chrono-Log Whole Blood Aggregometer, Models 591A And 592A
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K032951 FDA 510(k)
- FDA Product Code
- JOZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5700 FDA 510(k)
- Regulation Number
- 864.5700 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Chrono-Log Whole Blood Aggregometer is an automated system for platelet aggregation. It is used in hematology to measure the aggregation of platelets in whole blood. The device is designed to provide accurate and reliable results. The Chrono-Log Whole Blood Aggregometer is available in models 591A and 592A.
The device is supplied in various configurations and is intended for use in a clinical setting. It is a non-single use device. The device has been authorized with an FDA 510K clearance. The Chrono-Log Whole Blood Aggregometer is stored and used according to the manufacturer's instructions and is subject to regulation under 864.5700.
Frequently asked questions
What is the Chrono-Log Whole Blood Aggregometer used for?
The Chrono-Log Whole Blood Aggregometer is used in hematology to measure the aggregation of platelets in whole blood, providing accurate and reliable results.
Is the Chrono-Log Whole Blood Aggregometer a single-use device?
No, the Chrono-Log Whole Blood Aggregometer is a non-single use device, intended for repeated use in a clinical setting.
How is the Chrono-Log Whole Blood Aggregometer stored and used?
The device is stored and used according to the manufacturer's instructions, and is subject to regulation under 864.5700.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032951 | Class II | Active |
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Manufacturer
- Manufacturer
- Chrono-Log Corp
- FDA Applicant
- Chrono-Log Corp.
Sources (1)
- FDA 510(k) K032951 24 fields · synced Sep 23, 2026