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Chrono-Log

FDA UDI

Class II (US FDA UDI)

by Chrono-Log Corp

Identity

Trade Name
CHRONO-LOG FDA UDI
Generic Name
Platelet aggregation analyser IVD FDA UDI
Device Name
vW CoFactor Opti8 Software FDA UDI
Model / Reference
vW CoFactor Opti8 Software FDA UDI
Description
vW CoFactor Opti8 Software FDA UDI

Identifiers

Primary DI / UDI-DI
00811476011670 FDA UDI
510(k) Number
K940792 FDA UDI
FDA Product Code
JBX FDA UDI
JOZ FDA UDI
GMDN Term
Platelet aggregation analyser IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.6675 FDA UDI
864.5700 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

No

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

No

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.

Cleared under the same submission

K940792 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Chrono-Log Corp

Sources (1)

  • FDA UDI 96b3d384-e967-43ad-bccb-9c218679bf9e 34 fields · synced Jun 8, 2026