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Chrono-log Platelet Aggregometer, 4 channel +1 more model
FDA 510(k)Class II (US FDA 510(k))
510(k) K161329
Identifiers
- 510(k) Number
- K161329 FDA 510(k)
- FDA Product Code
- JOZ FDA 510(k)
- Models / Variants
- Chrono-log Platelet Aggregometer, 4 channel FDA 510(k)Chrono-log Platelet Aggregometer, 8 channel 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)
Chrono-log Platelet Aggregometer, 4 channel +1 more model by Chrono-Log Corp — Class II — FDA_510K — listed in FDA 510(k) — 2 models
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 | K161329 | Class II | Active |
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Manufacturer
- Manufacturer
- Chrono-Log Corp
- FDA Applicant
- Chrono-Log Corp.
Sources (1)
- FDA 510(k) K161329 24 fields · synced Jun 18, 2026